FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K171629 |
ACRO Biomedical Co., Ltd. |
ABCcolla Bone Graft |
02/01/2018 |
K212156 |
ACRO Biomedical Co., Ltd. |
ABCcolla Bone Matrix |
10/08/2021 |
K091688 |
AG DIGITAL TECHNOLOGY CORP. |
A-GRIX RESORBABLE BONE VOID FILLER |
03/02/2010 |
K121453 |
AG DIGITAL TECHNOLOGY CORP. |
A-GRIX TE RESORABLE BONE VOID FILLER |
02/05/2013 |
K083279 |
AG DIGITAL TECHNOLOGY CORP. |
CALTRIX RESORBABLE BONE VOID FILLER |
01/28/2009 |
K181342 |
AgNovos Healthcare USA, LLC |
JGH1 Bone Graft Substitute |
07/19/2018 |
K181585 |
AgNovos Healthcare USA, LLC |
JGH1 Core Deccompression Procedure Kit |
07/20/2018 |
K071849 |
ALLOSOURCE, INC. |
ALLOFUSE GEL AND PUTTY |
12/04/2008 |
K103036 |
ALLOSOURCE, INC. |
ALLOFUSE PLUS |
01/10/2011 |
K161996 |
Amend Surgical, Inc. |
0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE |
02/16/2017 |
K050025 |
ANGSTROM MEDICA, INC. |
NANOSS BONE VOID FILLER |
02/03/2005 |
K173008 |
Anika Therapeutics, Inc. |
SCS 17-01 |
12/26/2017 |
K190956 |
Anika Therapeutics, Inc. |
SCS 17-01 |
01/30/2020 |
K223915 |
Anika Therapeutics. Inc. |
Tactoset |
03/29/2023 |
K212083 |
Anika Therapeutics. Inc. |
Tactoset Injectable Bone Substitute |
08/31/2021 |
K071206 |
APATECH LTD. |
ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE |
05/31/2007 |
K082575 |
APATECH LTD. |
ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES |
11/25/2008 |
K081979 |
APATECH LTD. |
ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE |
11/06/2008 |
K082073 |
APATECH LTD. |
ACTIFUSE FLOW BONE GRAFT SUBSTITUTE |
09/11/2008 |
K080736 |
APATECH LTD. |
ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE |
04/16/2008 |
K033722 |
APATECH LTD. |
APAPORE BONE GRAFT SUBSTITUTE |
05/07/2004 |
K040082 |
APATECH LTD. |
PORE-SI BONE GRAFT SUBSTITUTE |
08/04/2004 |
K040381 |
ARTHREX, INC. |
HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15 |
05/12/2004 |
K141189 |
ARTOSS GMBH |
NANOBONE / GRANULATE |
01/30/2015 |
K161351 |
ARTOSS GMBH |
NanoBone SBX Putty |
10/26/2016 |
K190110 |
Artoss Gmbh |
NanoBone SBX PUTTY, NanoBone QD |
04/23/2019 |
K031319 |
ASPINE USA, INC. |
OSTEO-G BONE VOID FILLER SYSTEM |
07/17/2003 |
K111018 |
ATPAC MEDICAL LLC |
POLYFUSE - NEUROBONE |
02/14/2012 |
K091321 |
BACTERIN INTERNATIONAL INC. |
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY |
09/11/2009 |
K150621 |
BACTERIN INTERNATIONAL INC. |
OsteoSelect PLUS Demineralized Bone Matrix Putty |
08/18/2015 |
K081717 |
BAXTER HEALTHCARE CORP. |
TRICOS A RESORBABLE BONE SUBSTITUTE |
10/10/2008 |
K051722 |
BAXTER HEALTHCARE CORP. |
TRICOS T |
11/18/2005 |
K130531 |
BAXTER HEALTHCARE CORP. |
ULTRAFUSE |
04/08/2014 |
K181306 |
Baxter Healthcare Corporation |
Actifuse Flow |
08/17/2018 |
K181225 |
Baxter Healthcare Corporation |
ALTAPORE |
08/31/2018 |
K192363 |
Baxter Healthcare Corporation |
Altapore |
01/09/2020 |
K201464 |
Baxter Healthcare Corporation |
Altapore MIS |
06/30/2020 |
K200640 |
Baxter Healthcare Corporation |
ALTAPORE SHAPE |
05/08/2020 |
K191513 |
Baxter Healthcare Corporation |
Altapore Shape |
10/19/2019 |
K141725 |
BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO, L |
BONGOLD BONE GRAFT MATERIAL |
07/09/2015 |
K170917 |
Berkeley Advanced Biomaterials |
Bi-Ostetic Bioactive Glass Foam |
10/30/2017 |
K091912 |
BERKELEY ADVANCED BIOMATERIALS, INC. |
B-GENIN AND R-GENIN |
06/23/2010 |
K113791 |
BERKELEY ADVANCED BIOMATERIALS, INC. |
B-GENIN, R-GENIN |
03/15/2012 |
K023703 |
BERKELEY ADVANCED BIOMATERIALS, INC. |
BI-OSTETIC |
01/30/2003 |
K092046 |
BERKELEY ADVANCED BIOMATERIALS, INC. |
BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY |
03/24/2010 |
K053213 |
BERKELEY ADVANCED BIOMATERIALS, INC. |
BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM |
07/06/2006 |
K042636 |
BERKELEY ADVANCED BIOMATERIALS, INC. |
BIOPLUS |
12/14/2004 |
K030266 |
BERKELEY ADVANCED BIOMATERIALS, INC. |
CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ |
02/20/2003 |
K040405 |
BERKELEY ADVANCED BIOMATERIALS, INC. |
CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY |
03/05/2004 |
K022622 |
BERKELEY ADVANCED BIOMATERIALS, INC. |
CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P |
01/09/2003 |
K051914 |
BERKELEY ADVANCED BIOMATERIALS, INC. |
GENEROS 80, GENEROS 60 |
11/03/2005 |
K050666 |
BERKELEY ADVANCED BIOMATERIALS, INC. |
GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES |
04/11/2005 |
K051695 |
BERKELEY ADVANCED BIOMATERIALS, INC. |
MARROW PLUS (M+) |
07/19/2005 |
K041889 |
BERKELEY ADVANCED BIOMATERIALS, INC. |
TRI-OSTETIC |
08/19/2004 |
K152589 |
Bio2 Technologies, Inc |
Bio2 CLM BG Bioactive Scaffold |
01/12/2016 |
K142463 |
Bio2 Technologies, Inc. |
Bio2 CLM BG Bioactive Scaffold |
12/18/2014 |
K212721 |
Biocomposites Ltd |
Genex Bone Graft Substitute |
02/04/2022 |
K043514 |
BIOCOMPOSITES LTD. |
ALLOGRAN-N-BONE VOID FILLER |
01/21/2005 |
K061311 |
BIOCOMPOSITES LTD. |
ALLOGRAN-R |
09/22/2006 |
K082381 |
BIOCOMPOSITES LTD. |
GENEX |
11/14/2008 |
K040600 |
BIOCOMPOSITES LTD. |
GENEX BONE GRAFT SUBSTITUTE |
05/07/2004 |
K073341 |
BIOCOMPOSITES LTD. |
GENEX PUTTY |
07/09/2008 |
K003954 |
BIOCOMPOSITES LTD. |
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT |
07/12/2001 |
K021551 |
BIOCOMPOSITES LTD. |
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT |
11/01/2002 |
K001724 |
BIOCOMPOSITES LTD. |
STIMULAN -CALCIUM SULFATE BONE VOID FILTER |
08/04/2000 |
K141830 |
BIOCOMPOSITES LTD. |
STIMULAN KIT, STIMULAN RAPID CURE |
01/23/2015 |
K973704 |
BIOGENERATION |
PROFUSION BONE VOID FILLER |
04/03/1998 |
K031838 |
BIOGENERATION |
PROFUSION BONE VOID FILLER KIT |
10/30/2003 |
K142828 |
BIOGENNIX |
osteoSPAN Morpheus |
01/15/2015 |
K193487 |
Biogennix, LLC |
Agilon Strip |
03/30/2020 |
K093342 |
BIOGENNIX, LLC |
BIOGENNIX RPC |
07/29/2010 |
K132377 |
BIOGENNIX, LLC |
OSTEOSPAN MORPHEUS |
05/20/2014 |
K193168 |
Biogennix, LLC. |
Agilon Moldable |
02/13/2020 |
K190371 |
Biogennix, LLC. |
Morpheus-C |
08/09/2019 |
K032268 |
BIOMATLANTE |
MBCP |
12/11/2003 |
K051774 |
BIOMATLANTE |
MBCP |
01/20/2006 |
K063527 |
BIOMATLANTE |
MBCP+ |
07/30/2007 |
K043005 |
BIOMATLANTE |
MODIFICATION TO MBCP |
05/03/2005 |
K071121 |
BIOMATLANTE |
TRIBONE 80 |
09/11/2007 |
K041089 |
BIOMET MANUFACTURING, INC. |
OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM |
08/31/2004 |
K032286 |
BIOMET ORTHOPEDICS, INC. |
CALCIGEN PSI BONE GRAFT SUBSTITUTE |
11/20/2003 |
K013790 |
BIOMET ORTHOPEDICS, INC. |
CALCIGEN-S BONE VOID FILER |
06/11/2002 |
K070864 |
BIOMET OSTEOBIOLOGICS |
BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER |
06/01/2007 |
K082793 |
BIOMET SPINE |
INTERGRO DBM |
04/02/2009 |
K033611 |
BIOMET, INC. |
CALCIGEN -NAP BONE VOID FILLER |
04/27/2004 |
K030178 |
BIOMET, INC. |
CALCIGEN PSI BONE GRAFT SUBSTITUTE |
02/26/2003 |
K011531 |
BIOMET, INC. |
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER |
09/06/2002 |
K051775 |
BIOMIMETIC PHARMACEUTICALS INC. |
OSTEOMIMETIC SYNTHETIC BONE MATRIX |
09/06/2005 |
K202639 |
Biostone Ltd |
si-Mochi |
04/21/2021 |
K092541 |
BIOSTRUCTURES |
INTERFACE |
11/09/2010 |
K132071 |
BIOSTRUCTURES, LLC |
BIOACTIVE BONE GRAFT PUTTY |
01/10/2014 |
K112857 |
BIOSTRUCTURES, LLC |
INTERFACE BONE VOID FILLER |
12/13/2011 |
K160446 |
BioStructures, LLC |
MCP Bone Putty |
11/07/2016 |
K142276 |
BIOSTRUCTURES, LLC |
MCS Bone Graft |
01/16/2015 |
K193513 |
Bioventus |
SIGNAFUSE Bioactive Bone Graft |
06/18/2020 |
K162860 |
BIOVENTUS LLC |
MCS Bone Graft |
02/13/2017 |
K191274 |
BonAlive Biomaterials Ltd. |
BonAlive Granules |
08/07/2019 |
K231528 |
Bonalive Biomaterials, Ltd. |
Bonalive Orthopedics granules |
07/11/2023 |
K221256 |
Bone Solutions, Inc. |
Mg OSTEOINJECT |
06/28/2022 |
K071004 |
BONE SOLUTIONS, INC. |
OSTEOCRETE BONE VOID FILLER |
05/21/2009 |
K212991 |
Bone Solutions, Inc. |
Osteorevive |
01/21/2022 |
K051951 |
BONE SUPPORT AB |
CERAMENT BONE VOID FILLER |
09/28/2005 |
K201535 |
BoneSupport AB |
Cerament Bone Void Filler |
10/16/2020 |
K073316 |
BONESUPPORT AB |
CERAMENT BONE VOID FILLER, MODEL A0210 |
06/20/2008 |
K090871 |
BONESUPPORT AB |
CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 |
09/04/2009 |
K070220 |
CALCITEC, INC |
OSTEOFIX BONE VOID FILLER |
04/12/2007 |
K050357 |
CAM IMPLANTS B.V. |
CAMCERAM TCP |
04/21/2005 |
K180121 |
Cellumed Co., Ltd. |
Rafugen DBM |
04/11/2018 |
K033679 |
CENTERPULSE SPINE-TECH, INC. |
COPSIOS BONE VOID FILLER (BVF) |
07/07/2004 |
K013960 |
CERABIO, LLC |
APATIGHT HA-BONE GRAFT SUBSTITUTE |
05/23/2002 |
K013966 |
CERABIO, LLC |
APATIGHT-TCP BONE GRAFT SUBSTITUTE |
05/16/2002 |
K062200 |
COLLAGEN MATRIX, INC. |
COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS |
02/13/2007 |
K231942 |
Collagen Matrix, Inc. |
Mineral Collagen Composite Bioactive Extra Moldable |
08/02/2023 |
K182074 |
Collagen Matrix, Inc. |
Mineral Collagen Composite Bioactive Moldable |
03/21/2019 |
K221735 |
Collagen Matrix, Inc. |
Mineral Collagen Composite Bioactive Moldable |
12/20/2022 |
K052812 |
COLLAGEN MATRIX, INC. |
OSSIMEND (TM) BONE GRAFT MATERIAL |
01/25/2006 |
K092608 |
COLLAGEN MATRIX, INC. |
SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX |
05/28/2010 |
K223563 |
Converg Engineering |
OsteoCNX |
01/25/2023 |
K220337 |
Corliber (Shenzhen) Medical Device Co., Ltd. |
GaiaBone Bioabsorbable Bone Graft |
02/03/2023 |
K100841 |
CURASAN AG |
BONEOPTIMIZER |
08/19/2010 |
K181721 |
curasan AG |
Ceracell Ortho Foam |
09/17/2018 |
K040216 |
CURASAN AG |
CERASORB M ORTHO |
03/26/2004 |
K014156 |
CURASAN AG |
CERASORB ORTHO |
03/18/2002 |
K160566 |
CURASAN AG |
Cerasorb Ortho Foam |
12/02/2016 |
K031651 |
CURASAN AG |
MODIFICATION TO CERASORB ORTHO |
08/13/2003 |
K102937 |
CYTOPHIL INC |
OSTEOPHIL BETA-TCP |
12/27/2010 |
K014053 |
DEPUY ACROMED |
CONDUIT TCP GRANULES |
03/08/2002 |
K011048 |
DEPUY ORTHOPAEDICS, INC. |
BSM BONE SUBSTITUTE MATERIAL |
11/13/2001 |
K062495 |
DEPUY SPINE, INC. |
HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM |
10/13/2006 |
K081758 |
DEPUY SPINE, INC. |
HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015 |
09/03/2008 |
K043308 |
DEPUY SPINE, INC. |
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL |
02/16/2005 |
K171161 |
Dimensional Bioceramics LLC |
Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) |
09/25/2017 |
K210193 |
Dimensional Bioceramics, LLC |
DB-Composite |
03/15/2021 |
K200752 |
Dimensional Bioceramics, LLC |
DB-Orthopedics |
04/22/2020 |
K212353 |
Dimensional Bioceramics, LLC. |
DB-EZ Bone Void Filler |
09/22/2021 |
K230054 |
DSM Biomedical |
DSM Biomedical Calcium Phosphate Cement |
03/21/2023 |
K011386 |
EBI, L.P. |
EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE |
08/03/2001 |
K063346 |
EBI, L.P. |
PRO OSTEON 500R |
04/18/2007 |
K090401 |
ED. GEISTLICH SOEHNE AG FUR CHEMISCHE INDUSTRIE |
ORTHOSS |
01/08/2010 |
K180853 |
Elute, Inc. |
EP GranulesÖ BVF |
08/06/2018 |
K982663 |
ENCORE ORTHOPEDICS, INC. |
STIMULAN- CALCIUM SULFATE BONE VOID FILLER |
02/26/1999 |
K072636 |
ETEX CORP. |
A-BSM BONE SUBSTITUTE MATERIAL |
10/23/2007 |
K091607 |
ETEX CORP. |
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE |
11/02/2009 |
K063050 |
ETEX CORP. |
CAP PLUS |
11/19/2007 |
K033138 |
ETEX CORP. |
CAP3 BONE SUBSTITUTE MATERIAL |
12/02/2003 |
K093447 |
ETEX CORP. |
CARRIGEN |
02/18/2010 |
K090310 |
ETEX CORP. |
EQUIVABONE |
03/24/2009 |
K090855 |
ETEX CORP. |
EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE |
09/18/2009 |
K090242 |
ETEX CORP. |
GAMMA-BSM, BETA-BSM |
02/20/2009 |
K101557 |
ETEX CORP. |
GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN |
07/01/2010 |
K072355 |
ETEX CORP. |
OSSIFUSE BONE SUBSTITUTE MATERIAL |
09/26/2007 |
K062630 |
ETEX CORP. |
OSSIPRO BONE SUBSTITUTE MATERIAL |
06/28/2007 |
K132868 |
ETEX CORPORATION |
CARRICELL |
02/20/2015 |
K182107 |
ETEX Corporation |
CarriGen PF |
08/31/2018 |
K020078 |
EXACTECH, INC. |
EXACTECH RESORBABLE BONE PASTE |
02/27/2004 |
K040755 |
EXACTECH, INC. |
EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE |
06/17/2004 |
K121989 |
EXACTECH, INC. |
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC, |
11/27/2012 |
K190754 |
Geistlich Pharma AG |
Orthoss(R) |
06/23/2019 |
K130392 |
GLOBUS MEDICAL INC. |
KINEX BIOACTIVE |
08/15/2013 |
K102392 |
GLOBUS MEDICAL INC. |
MICROFUSE PUTTY AND MICROFUSE ST MIS |
12/22/2010 |
K083232 |
GLOBUS MEDICAL INC. |
MODIFICATION TO:MICROFUSE BONE VOID FILLER |
12/24/2008 |
K130977 |
GLOBUS MEDICAL INC. |
SIGNIFY BIOACTIVE |
12/24/2013 |
K133678 |
GLOBUS MEDICAL, INC. |
CONFIRM BIOACTIVE |
08/26/2014 |
K071187 |
GLOBUS MEDICAL, INC. |
MICROFUSE BONE VOID FILLER |
12/20/2007 |
K082442 |
GLOBUS MEDICAL, INC. |
MODIFICATION TO MICROFUSE BONE VOID FILLER |
10/07/2008 |
K093343 |
GRAFTYS |
GRAFTY QUICKSET |
04/22/2010 |
K073064 |
GRAFTYS |
GRAFTYS BCP |
03/11/2008 |
K082498 |
GRAFTYS |
GRAFTYS HBS |
02/25/2009 |
K231714 |
Graftys |
Graftys Quickset |
07/12/2023 |
K072444 |
GWOWEI TECHNOLOGY CO., LTD. |
WELLGRAFT PE I |
04/04/2008 |
K072170 |
GWOWEI TECHNOLOGY CO., LTD. |
WELLGRAFT PE II |
04/04/2008 |
K141429 |
HAIDER BIOLOGICS, LLC |
SORRENTO BONE GRAFT SUBSTITUTE |
02/23/2015 |
K151271 |
Hans Biomed Corp. |
BellaFuse |
03/11/2016 |
K152077 |
HANS BIOMED CORP. |
MaxiGen |
04/21/2016 |
K171568 |
Hans Biomed Corporation |
SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty |
02/22/2018 |
K033258 |
HOWMEDICA OSTEONICS |
BONESAVE BONE VOID FILLER |
03/09/2004 |
K031435 |
HOWMEDICA OSTEONICS |
BONESOURCE BVF |
08/04/2003 |
K001559 |
HOWMEDICA OSTEONICS CORP. |
CALCIUM SULFATE PELLETS |
06/20/2000 |
K120602 |
HOYA CORPORATION |
APACERAM BONE GRAFT SUBSTITUTE |
03/23/2012 |
K070998 |
INION OY |
INION BIORESTORE |
10/11/2007 |
K191764 |
Inion Oy |
Inion BioRestore |
07/31/2019 |
K090177 |
INION OY |
INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE |
02/20/2009 |
K141841 |
INTEGRA LIFESCIENCE CORPORTATION |
INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP |
08/01/2014 |
K063124 |
INTEGRA LIFESCIENCES CORP. |
INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS |
01/19/2007 |
K091302 |
INTEGRA LIFESCIENCES CORPORATION |
INTEGRA MOZAIK AND OS MOLDABLE MORSELS |
12/04/2009 |
K062353 |
INTEGRA LIFESCIENCES CORPORATION |
MOZAIK BONE REGENERATION MATRIX - PUTTY |
12/20/2006 |
K031399 |
INTERPORE CROSS INTL. |
INTERGRO DBM |
02/18/2005 |
K991854 |
INTERPORE CROSS INTL. |
OSTEOPLAST, MODEL POP200 |
08/26/1999 |
K000515 |
INTERPORE CROSS INTL. |
PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, |
09/15/2000 |
K004003 |
INTERPORE CROSS INTL. |
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30 |
07/19/2001 |
K990131 |
INTERPORE CROSS INTL. |
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE |
03/02/1999 |
K980817 |
INTERPORE INTL. |
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L |
09/25/1998 |
K082419 |
INTRA-LOCK INTERNATIONAL, INC. |
REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 |
05/27/2009 |
K061880 |
ISOTIS NV |
ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC |
08/15/2007 |
K030131 |
ISOTIS NV |
OSSATURA BCP BONE VOID FILLER |
05/20/2003 |
K050690 |
ISOTIS ORTHOBIOLOGICS, INC |
CONNEXUS |
07/07/2005 |
K052098 |
ISOTIS ORTHOBIOLOGICS, INC |
CONNEXUS, .5CC, MODEL 023000-005 |
09/07/2005 |
K040419 |
ISOTIS ORTHOBIOLOGICS, INC |
DYNAGRAFT II |
03/25/2005 |
K070751 |
ISOTIS ORTHOBIOLOGICS, INC |
ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY |
10/15/2007 |
K063359 |
ISTO TECHNOLOGIES, INC. |
INQU |
04/16/2007 |
K071428 |
ISTO TECHNOLOGIES, INC. |
INQU |
09/17/2007 |
K111838 |
ISTO TECHNOLOGIES, INC. |
INQU PASTE MIX |
09/26/2011 |
K103799 |
ISTO TECHNOLOGIES, INC. |
INQU PASTE MIX PLUS |
08/29/2011 |
K073214 |
KASIOS |
DUOWEDGE SYNTHETIC BONE SUBSTITUTE |
12/01/2009 |
K042340 |
KASIOS BIOMATERIALS |
KASIOS TCP |
11/24/2004 |
K120141 |
KENSEY NASH CORORATION |
KENSEY NASH BONE VOID FILLER XC |
05/04/2012 |
K071237 |
KENSEY NASH CORP. |
COPIOS BONE VOID FILLER SPONGE AND PASTE |
06/01/2007 |
K072384 |
KENSEY NASH CORP. |
MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE |
09/21/2007 |
K060917 |
KENSEY NASH CORPORATION |
KENSEY NASH BONE VOID FILLER |
09/22/2006 |
K173362 |
Kensey Nash Corporation dba DSM Biomedical |
DSM Biomedical Calcium Phosphate Cement |
04/03/2018 |
K173572 |
Kensey Nash Corporation dba DSM Biomedical |
DSM Biomedical Calcium Phosphate Cement with Microspheres |
05/09/2018 |
K211201 |
Kuros Biosciences B.V. |
MagnetOs Easypack Putty |
09/02/2021 |
K181958 |
Kuros Biosciences B.V. |
MagnetOs Putty |
12/06/2018 |
K171563 |
Kuros Biosciences B.V. |
MagnetOs Putty |
08/24/2017 |
K213959 |
Kuros Biosciences BV |
MagnetOs Flex Matrix |
04/14/2022 |
K213111 |
Kuros Biosciences BV |
MagnetOs granules |
01/10/2022 |
K082338 |
KYUNGWON MEDICAL CO., LTD. |
POLYBONE GRANULE & BLOCK |
10/16/2008 |
K043347 |
LDR SPINE USA |
BF+ |
01/07/2005 |
K061462 |
LDR SPINE USA |
BF+ (PH) |
12/15/2006 |
K191670 |
Linacol Muh Dan Kim Cev Tek Med Ith Ihr San Ve Tic |
CureOs TCP |
08/04/2020 |
K041177 |
MEDARTIS MEDIZINPRODUKTE UND FORSCHUNG AG |
SYNTHACER; SYNTRICER |
06/23/2005 |
K070794 |
MEDICAL BIOMAT |
ATLANTIK |
07/10/2007 |
K050490 |
MEDICREA |
OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER |
04/11/2005 |
K071813 |
MEDTRONIC SOFAMOR DANEK |
MASTERGRAFT PUTTY |
11/09/2007 |
K082918 |
MEDTRONIC SOFAMOR DANEK |
MASTERGRAFT RESORBABLE CERAMIC GRANULES |
02/09/2009 |
K082166 |
MEDTRONIC SOFAMOR DANEK |
MASTERGRAFT STRIP |
06/02/2009 |
K072265 |
MEDTRONIC SOFAMOR DANEK |
PROGENIX DMB PUTTY |
01/09/2008 |
K082002 |
MEDTRONIC SOFAMOR DANEK |
PROGENIX PLUS |
11/24/2008 |
K151172 |
MEDTRONIC SOFAMOR DANEK USA, INC |
MASTERGRAFT Contain |
08/14/2015 |
K131673 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT |
10/03/2013 |
K140375 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MASTERGRAFT PUTTY, MASTERGRAFT STRIP |
04/18/2014 |
K012506 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MASTERGRAFT RESORBABLE CERAMIC GRANULES |
03/07/2002 |
K130335 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX |
04/19/2013 |
K123691 |
MEDTRONIC SOFAMOR DANEK, INC. |
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM) |
01/31/2013 |
K023553 |
MEDTRONIC SOFAMOR DANEK, INC. |
MASTERGRAFT MATRIX |
04/22/2003 |
K141824 |
MEDTRONIC SOFAMOR DANEK, INC. |
MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP |
09/05/2014 |
K020986 |
MEDTRONIC SOFAMOR DANEK, INC. |
MASTERGRAFT RESORBABLE CERAMIC |
07/22/2002 |
K051386 |
MEDTRONIC VASCULAR |
MASTERGRAFT PUTTY BONE VOID FILLER |
12/16/2005 |
K063157 |
MERRIES INTERNATIONAL INC. |
MERRIES K-PHATE BONE GRAFT SUBSTITUTE |
03/10/2008 |
K051698 |
MERRIES INTERNATIONAL INC. |
MERRIES UNI-OSTEO, MODEL CS30250-CS10102 |
09/29/2005 |
K070897 |
META BIOMED CO., LTD. |
BONEMEDIK, AND BONEMEDIK-S |
09/17/2007 |
K011726 |
MILLENIUM BIOLOGIX, INC. |
MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER |
05/16/2002 |
K170165 |
Molecular Matrix, Inc. |
Osteo-P Bone Graft Substitute |
12/29/2017 |
K042125 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
AFT |
07/28/2005 |
K091218 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
DBX DEMINERALIZED BONE MATRIX PUTTY |
09/28/2009 |
K103784 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
DBX DEMINERALIZED BONE MATRIX PUTTY |
04/13/2011 |
K103795 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
DBX DEMINERALIZED BONE MATRIX PUTTY |
04/13/2011 |
K040262 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX |
03/17/2005 |
K053218 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX |
12/28/2006 |
K110003 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
MTF NEW BONE VOID FILLER |
10/13/2011 |
K121313 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
MTF NEW BONE VOID FILLER |
01/11/2013 |
K113167 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
MTF NEW BONE VOILD FILLER |
01/24/2012 |
K120279 |
NANOTHERAPEUTICS |
NANOFUSE DBM |
04/06/2012 |
K062459 |
NANOTHERAPEUTICS |
ORIGEN DBM WITH BIOACTIVE GLASS |
02/26/2007 |
K142104 |
NANOTHERAPEUTICS, INC. |
NANOFUSE DBM |
01/21/2015 |
K110976 |
NANOTHERAPEUTICS, INC. |
ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM |
05/03/2011 |
K000122 |
NEUCOLL, INC. |
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX) |
09/20/2001 |
K051406 |
NEXA ORTHOPEDICS, INC. |
OSTEOCURE RESORBABLE BEAD KIT |
08/01/2005 |
K112773 |
NovaBone Products, LLC |
NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT |
10/14/2011 |
K041613 |
NovaBone Products, LLC |
NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE |
08/25/2004 |
K141207 |
NovaBone Products, LLC |
NOVABONE BIOACTIVE STRIP |
10/31/2014 |
K163310 |
NovaBone Products, LLC |
NovaBone IRM |
01/18/2017 |
K140946 |
NovaBone Products, LLC |
NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE |
08/22/2014 |
K152071 |
NOVABONE PRODUCTS, LLC |
NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) |
08/26/2015 |
K110925 |
NovaBone Products, LLC |
NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT |
07/05/2011 |
K090731 |
NovaBone Products, LLC |
NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD |
04/15/2009 |
K060432 |
NovaBone Products, LLC |
NOVABONE POROUS-BONE GRAFT SCAFFOLD |
04/04/2006 |
K110368 |
NovaBone Products, LLC |
NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT |
04/14/2011 |
K060728 |
NovaBone Products, LLC |
NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT |
05/01/2006 |
K051617 |
NovaBone Products, LLC |
NOVABONE PUTTY - RESORBABLE BONE VOID FILLER |
03/06/2006 |
K101860 |
NovaBone Products, LLC |
NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT |
09/01/2010 |
K080009 |
NovaBone Products, LLC |
NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT |
05/06/2008 |
K082672 |
NovaBone Products, LLC |
NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT |
12/09/2008 |
K052494 |
NovaBone Products, LLC |
NOVABONE-BIOACTIVE SYNTHETIC GRAFT |
11/03/2005 |
K021336 |
NovaBone Products, LLC |
NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE |
07/25/2002 |
K191974 |
NuVasive, Incorporated |
NuVasive AttraX Putty |
11/03/2019 |
K172497 |
NuVasive, Incorporated |
NuVasive AttraX Scaffold |
11/24/2017 |
K061499 |
OLYMPUS AMERICA, INC. |
OSFERION |
01/26/2007 |
K080065 |
OLYMPUS TERUMO BIOMATERIALS CORPORATION |
OSFERION |
05/02/2008 |
K140913 |
ORIENTAL RESOURCES DEVELOPMENT LIMITED |
NUROS BONE GRAFT SUBSTITUTE |
02/17/2015 |
K012751 |
ORQUEST, INC. |
HEALOS BONE GRAFT MATERIAL |
11/14/2001 |
K231270 |
Orthocon, Inc. |
Montage Flowable Settable, Resorbable Bone Paste |
09/01/2023 |
K222063 |
Orthocon, Inc. |
MONTAGE Settable, Resorbable Bone Putty |
02/03/2023 |
K231903 |
Orthocon, Inc. |
Montage-QS Settable, Resorbable Bone Putty |
08/25/2023 |
K110787 |
ORTHOGEM LIMITED |
TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15) |
04/21/2011 |
K070132 |
ORTHOGEM LIMITED |
TRIPORE, MODELS HA, BP90, BP15 |
07/13/2007 |
K150064 |
ORTHOGEM LTD |
Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15) |
09/04/2015 |
K142090 |
ORTHOREBIRTH CO., LTD. |
REBOSSIS |
10/29/2014 |
K170620 |
ORTHOREBIRTH Co., Ltd. |
ReBOSSIS85 |
06/23/2017 |
K172573 |
Orthorebirth Co., Ltd. |
ReBOSSIS85 |
12/15/2017 |
K041616 |
ORTHOS (UK) LIMITED |
BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID |
08/25/2004 |
K040514 |
ORTHOTEC, L.L.C. |
EOVIA CALCIUM PHOSPHATE CERAMIC |
05/03/2004 |
K994337 |
ORTHOVITA CO. |
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER |
12/14/2000 |
K102545 |
ORTHOVITA, INC. |
FM-02 BONE GRAFT SUBSTITUTE |
10/27/2010 |
K161447 |
ORTHOVITA, INC. |
HydroSet XT |
10/06/2016 |
K103173 |
ORTHOVITA, INC. |
VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE |
02/07/2011 |
K153608 |
ORTHOVITA, INC. |
Vitoss BiModal Bone Graft Substitute Foam Strip |
02/12/2016 |
K163621 |
Orthovita, Inc. |
Vitoss Bioactive (BA) Injectable |
05/02/2017 |
K072184 |
ORTHOVITA, INC. |
VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE |
09/18/2007 |
K081439 |
ORTHOVITA, INC. |
VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE |
06/17/2008 |
K083033 |
ORTHOVITA, INC. |
VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE |
11/06/2008 |
K032288 |
ORTHOVITA, INC. |
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL |
12/19/2003 |
K032409 |
ORTHOVITA, INC. |
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER |
08/29/2003 |
K032130 |
ORTHOVITA, INC. |
VITOSS-FILLED CARTRIDGE |
11/05/2003 |
K051047 |
OSSACUR AG |
COLLOSS E BONE VOID FILLER |
03/08/2006 |
K050416 |
OSSACUR AG |
OSSAPLAST ORTHO |
03/29/2005 |
K042305 |
OSSACUR AG |
OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903 |
10/21/2004 |
K232315 |
OssDsign AB |
Catalyst Bone Void Filler |
09/15/2023 |
K040047 |
OSTEOBIOLOGICS, INC. |
POLYGRAFT BGS; BONE GRAFT SUBSTITUTE |
12/17/2004 |
K030288 |
OSTEOBIOLOGICS, INC. |
POLYGRAFT BONE GRAFT SUBSTITUTE |
07/17/2003 |
K033707 |
OSTEOBIOLOGICS, INC. |
POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX |
08/16/2004 |
K162087 |
OsteoNovus, Inc. |
NovoGro |
04/18/2017 |
K173525 |
OsteoNovus, Inc. |
NovoGro |
04/06/2018 |
K082615 |
OSTEOTECH INC |
GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES |
10/16/2008 |
K073405 |
OSTEOTECH, INC. |
PLEXUR M |
03/03/2008 |
K081227 |
OSTEOTECH, INC. |
PLEXUR M |
07/22/2008 |
K080511 |
OSTEOTECH, INC. |
PLEXUR-P |
04/21/2008 |
K071912 |
PENTAX CORP. |
APACERAM BONE GRAFT SUBSTITUTE |
10/29/2007 |
K083449 |
PIONEER SURGICAL TECHNOLOGY |
E-MATRIX GRAFT BONE EXTENDER |
06/12/2009 |
K110561 |
PIONEER SURGICAL TECHNOLOGY |
FORTROSS BONE VOID FILLER |
04/29/2011 |
K100361 |
PIONEER SURGICAL TECHNOLOGY |
NANOSS BONE VOID FILLER |
04/22/2010 |
K091031 |
PIONEER SURGICAL TECHNOLOGY |
PIONEER SURGICAL NANOSS BVF-E |
11/17/2009 |
K081558 |
PIONEER SURGICAL TECHNOLOGY |
PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC |
08/25/2008 |
K132050 |
PIONEER SURGICAL TECHNOLOGY, INC |
NB3D BONE VOID FILLER |
02/07/2014 |
K111944 |
PIONEER SURGICAL TECHNOLOGY, INC. |
NB3D BONE VOID FILLER |
11/22/2011 |
K141600 |
PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I |
NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT |
10/17/2014 |
K151584 |
PROGENTIX ORTHOBIOLOGY B.V. |
AttraX Putty |
10/08/2015 |
K090641 |
PROGENTIX ORTHOBIOLOGY B.V. |
CURIOS |
10/23/2009 |
K060809 |
PROMED ADVANCE TECHNOLOGY CO., LTD. |
OSTEO-LINK BONE VOID FILLER PELLETS |
07/03/2006 |
K151154 |
PROSIDYAN INC. |
FIBERGRAFT BG Morsels |
11/10/2015 |
K132805 |
PROSIDYAN, INC |
BG MORSELS |
03/14/2014 |
K182670 |
Prosidyan, Inc |
FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute |
12/20/2018 |
K213803 |
Prosidyan, Inc |
FIBERGRAFT Aeridyan Matrix Bone Graft Substitute |
08/23/2022 |
K171284 |
Prosidyan, Inc |
FIBERGRAFT BG Matrix Bone Graft Substitute |
06/30/2017 |
K180080 |
Prosidyan, Inc |
FIBERGRAFT BG Matrix Bone Graft Substitute |
04/06/2018 |
K141956 |
PROSIDYAN, INC |
FIBERGRAFT BG MORSELS |
08/13/2014 |
K170306 |
Prosidyan, Inc |
FIBERGRAFT BG Putty Bone Graft Substitute |
05/24/2017 |
K143533 |
PROSIDYAN, INC. |
FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE |
03/25/2015 |
K050789 |
R AND D MEDICAL, LLC |
FORMAGRAFT COLLAGEN BONE GRAFT MATRIX |
05/27/2005 |
K072238 |
REGENERATION TECHNOLOGIES, INC. |
BIOSET XCH |
01/25/2008 |
K072327 |
REGENERATION TECHNOLOGIES, INC. |
CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON |
10/24/2007 |
K043421 |
REGENERATION TECHNOLOGIES, INC. |
OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC |
02/16/2005 |
K043420 |
REGENERATION TECHNOLOGIES, INC. |
OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE |
02/10/2005 |
K051615 |
REGENERATION TECHNOLOGIES, INC. |
STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES |
08/15/2005 |
K130953 |
SBM SCIENCES FOR BIO MATERIALS |
NEOTIS; NEOTIS 50 |
07/15/2013 |
K061022 |
SCIENCE FOR BIOMATERIALS |
BIO 1-KIT BIOSORB FILLED CARTRIDGE |
05/24/2006 |
K071155 |
SCIENCE FOR BIOMATERIALS |
MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER |
07/03/2007 |
K021963 |
SCIENCES ET BIO MATERIAUX (SBM) |
BIOSORB RESORBABLE VOID FILLER |
01/28/2003 |
K040454 |
SCIENT'X |
BIOFILL BONE VOID FILLER |
05/07/2004 |
K212135 |
SeaSpine Corporation |
Dry DBM- A Putty |
10/04/2021 |
K231030 |
SeaSpine Orthopedics Corporation |
Cove Putty, OsteoCove Putty |
09/14/2023 |
K230486 |
SeaSpine Orthopedics Corporation |
Cove Strip |
08/21/2023 |
K232668 |
SeaSpine Orthopedics Corporation |
Cove Strip, OsteoCove Strip |
09/27/2023 |
K172130 |
SeaSpine Orthopedics Corporation |
Resorbable Mesh Device |
11/16/2017 |
K193040 |
SeaSpine Orthopedics Corporation |
Resorbable Mesh Device |
11/30/2019 |
K200290 |
SeaSpine Orthopedics Corporation |
Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) |
05/11/2020 |
K090387 |
SIGNUS MEDIZINTECHNIK GMBH |
KAINOS+ |
09/28/2009 |
K193075 |
Sirakoss Ltd. |
Osteo3 ZP Putty |
06/09/2020 |
K120354 |
SKELETAL KINETICS, LLC |
BETA-TCP GRANULES |
03/21/2013 |
K030554 |
SKELETAL KINETICS, LLC |
CALLOS |
05/20/2003 |
K100986 |
SKELETAL KINETICS, LLC |
CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION |
07/20/2010 |
K051123 |
SKELETAL KINETICS, LLC |
CALLOS IMPACT AND INJECT BONE VOID FILLER |
06/03/2005 |
K112383 |
SKELETAL KINETICS, LLC |
CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER |
02/07/2012 |
K132211 |
SKELETAL KINETICS, LLC |
SKAFFOLD NMX BONE VOID FILLER |
08/04/2014 |
K010555 |
SMITH & NEPHEW, INC. |
JAX |
02/25/2003 |
K010557 |
SMITH & NEPHEW, INC. |
JAX GRANULES BONE VOID FILLER |
05/25/2001 |
K033552 |
SMITH & NEPHEW, INC. |
JAX-TCP |
06/10/2004 |
K062607 |
SMITH & NEPHEW, INC. |
POLYGRAFT BGS |
11/09/2007 |
K062496 |
SPINECRAFT, INC. |
OSTEOPORE TCP |
10/19/2006 |
K132470 |
SPINESMITH PARTNERS, LLP |
SOLUM IV BONE VOID FILLER |
05/21/2014 |
K041421 |
STRYKER BIOTECH |
NAME BONE VOID FILLER |
08/26/2004 |
K060061 |
STRYKER CORP. |
STRYKER INJECTABLE CEMENT |
03/01/2006 |
K051603 |
STRYKER LEIBINGER MICRO IMPLANTS |
STRYKER INJECTABLE CEMENT |
12/30/2005 |
K200064 |
SurGenTec, LLC |
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft |
08/14/2020 |
K231716 |
SurGenTec, LLC |
OsteoFlo« HydroPuttyÖ |
10/02/2023 |
K173424 |
Synergy Biomedical |
BioSphere Flex |
09/12/2018 |
K140844 |
SYNERGY BIOMEDICAL, INC. |
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC |
07/16/2014 |
K122868 |
Synergy Biomedical, LLC |
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY |
04/19/2013 |
K173301 |
Synergy Biomedical, Llc |
BioSphere MIS Putty (BioSphere MIS) |
01/19/2018 |
K013072 |
SYNTHES |
CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) |
11/26/2002 |
K060408 |
SYNTHES (USA) |
NORIAN SRS BONE VOID FILLER |
03/21/2006 |
K011897 |
SYNTHES (USA) |
NORIAN SRS BONE VOID FILLER |
12/20/2001 |
K060406 |
SYNTHES (USA) |
NORIAN SRS FAST SET PUTTY |
03/20/2006 |
K041842 |
SYNTHES (USA) |
NORIAN SRS FAST SET PUTTY |
07/23/2004 |
K023862 |
SYNTHES (USA) |
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER |
12/19/2002 |
K043045 |
SYNTHES (USA) |
SYNTHES (USA) CHRONOS |
01/07/2005 |
K002362 |
SYNTHES (USA) |
SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) |
11/01/2000 |
K071046 |
SYNTHES (USA) |
SYNTHES CHRONOS COMPOSITE |
10/23/2007 |
K102722 |
SYNTHES USA PRODUCTS LLC |
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY |
01/27/2011 |
K062691 |
TAKIRON CO., LTD |
COMPORUS |
04/15/2008 |
K143692 |
TCM ASSOCIATES LTD |
GranOSTM - beta tricalcium phosphate synthetic bone granules |
08/21/2015 |
K041493 |
TEKNIMED SA |
CEMENTEK |
08/19/2004 |
K042911 |
TEKNIMED SA |
CEMENTEK LV |
12/27/2004 |
K040669 |
TEKNIMED SA |
CERAFORM BONE VOID FILLER |
05/03/2004 |
K031826 |
TEKNIMED SA |
TRIHA + |
11/28/2003 |
K031040 |
THERICS, INC. |
THERIFIL BONE FILLER |
07/24/2003 |
K040134 |
THERICS, INC. |
THERILINK BONE VOID FILLER |
03/09/2004 |
K053228 |
THERICS, LLC |
THERIGRAFT TCP PUTTY BONE VOID FILLER |
01/31/2006 |
K071876 |
TRIMED, INC. |
CROSS.BONE |
12/17/2007 |
K221644 |
Ventris Medical |
Synthetic Bone Putty |
09/02/2022 |
K131133 |
VIVORTE, INC |
VIVORTE BVF LITE |
08/12/2013 |
K143549 |
VIVORTE, INC |
Vivorte Trabexus |
01/14/2015 |
K071199 |
VIVOXID LTD. |
BONALIVE GRANULES |
02/01/2008 |
K110949 |
WILTROM CORPORATION LIMITED |
BICERA (TM) RESORBABLE BONE SUBSTITUTE |
09/18/2012 |
K172237 |
Wiltrom Corporation Limited |
Bicera Resorbable Bone Substitute |
02/02/2018 |
K180758 |
Wiltrom Corporation Limited |
Osteocera Resorbable Bone Substitute |
10/24/2018 |
K040980 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T |
07/14/2004 |
K053319 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ALLOMATRIX CUSTOM |
03/06/2006 |
K020895 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ALLOMATRIX MODEL# 86 |
03/05/2004 |
K041168 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ALLOMATRIX PUTTY |
08/02/2004 |
K041663 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM |
09/16/2004 |
K141746 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
AS20 COMPOSITE GRAFT |
08/04/2014 |
K031817 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
CELLPLEX TCP SYNTHETIC CANCELLOUS BONE |
07/17/2003 |
K190482 |
Wright Medical Technology, Inc. |
IGNITE Bone Void Filler |
05/28/2019 |
K052913 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
IGNITE BONE VOID FILLER KIT |
11/07/2005 |
K024336 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MIIG II BONE GRAFT SUBSTITUTE |
03/04/2003 |
K060011 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MIIG SR |
02/27/2006 |
K061939 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MODIFICATION TO ALLOMATRIX CUSTOM |
07/18/2006 |
K010532 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
OSTEOSET BVF KIT |
10/26/2001 |
K022828 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
OSTEOSET DBM PELLETS, MODEL 8600-48XX |
04/02/2004 |
K113871 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
PRO-DENSE BONE GRAFT SUBSTITUTE |
03/25/2013 |
K070437 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
PRO-DENSE BONE VOID FILLER |
05/09/2007 |
K072597 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT |
10/15/2007 |
K200507 |
Wright Medical Technology, Inc. |
PRO-DENSE LoVisc Bone Graft Substitute |
10/21/2020 |
K213342 |
Wright Medical Technology, Inc. |
PRO-DENSE LoVisc Bone Graft Substitute |
01/05/2022 |
K181255 |
Wright Medical Technology, Inc. |
PRODENSE Bone Graft Substitute |
09/12/2018 |
K182823 |
Wright Medical Technology, Inc. |
PRODENSE Bone Graft Substitute |
11/02/2018 |
K132656 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
PRODENSE BONE GRAFT SUBSTITUTE |
03/24/2014 |
K190283 |
Wright Medical Technology, Inc. |
PROSTIM Injectable Inductive Graft |
03/14/2019 |
K083270 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WMT COMPOSITE DBM |
08/27/2009 |
K022629 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WMT-TCP BONE GRAFT SUBSTITUTE |
11/05/2002 |
K963587 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION) |
03/24/1997 |
K963562 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WRIGHT PLASTER OF PARIS PELLETS |
05/07/1997 |
K960978 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION) |
06/21/1996 |
K173933 |
Xenco Medical, LLC |
Sorrento Bioglass Bone Graft Substitute |
09/13/2018 |
K191074 |
Xenco Medical, LLC |
Sorrento Bone Graft Substitute |
09/27/2019 |
K161859 |
XPAND BIOTECHNOLOGY BV |
MagnetOs |
02/24/2017 |
K221726 |
Zavation Medical Products, LLC |
Uni-FuZe-C Bone Strip |
01/18/2023 |
K201781 |
Zavation Medical Products, LLC |
Uni-FuZe-P Bone Putty |
12/28/2020 |
K203218 |
Zimmer Biomet Spine Inc. |
CaP Spheres Pellet Pack |
05/04/2021 |
K190814 |
Zimmer Knee Creations |
AccuFill Bone Substitute Material |
06/10/2019 |