FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K111883 |
A-SPINE ASIA, CO., LTD |
SMARTLOC SPINAL FIXATION SYSTEM |
10/18/2011 |
K062505 |
ABBOTT SPINE, INC. |
NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES |
09/26/2006 |
K052566 |
ABBOTT SPINE, INC. |
NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY |
01/06/2006 |
K060634 |
ABBOTT SPINE, INC. |
NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES |
03/31/2006 |
K132365 |
ACCEL SPINE |
SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION |
08/20/2013 |
K071824 |
ACME SPINE, LLC. |
ACME TALON PEDICLE SCREW |
09/04/2007 |
K980485 |
ACROMED CORP. |
ISOLA SPINAL SYSTEM |
10/21/1998 |
K033150 |
ADVANCED MEDICAL TECHNOLOGIES AG |
ART POSTERIOR SPINAL SYSTEM |
03/01/2004 |
K992147 |
ADVANCED SPINE TECHNOLOGY, INC. |
TRIPLE-FIX SPINAL FIXATION SYSTEM |
02/28/2000 |
K980484 |
AESCULAP, INC. |
AESCULAP SPINE SYSTEM EVOLUTION |
10/02/1998 |
K982914 |
AESCULAP, INC. |
AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS |
10/02/1998 |
K060152 |
AESCULAP, INC. |
MODIFICATION TO S4 SPINAL SYSTEM |
02/03/2006 |
K050979 |
AESCULAP, INC. |
S4 SPINAL SYSTEM |
07/27/2005 |
K050060 |
ALLEZ SPINE, LLC |
LAGUNA PEDICLE SCREW SYSTEM |
05/04/2005 |
K023299 |
ALPHATEC MFG., INC. |
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM |
12/11/2002 |
K063668 |
ALPHATEC SPINE, INC. |
ROC LUMBAR SYSTEM |
05/18/2007 |
K090779 |
ALPHATEC SPINE, INC. |
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM |
07/07/2009 |
K091189 |
ALPHATEC SPINE, INC. |
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM |
07/08/2009 |
K093077 |
ALPHATEC SPINE, INC. |
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM |
12/23/2009 |
K100138 |
ALPHATEC SPINE, INC. |
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM |
02/17/2010 |
K081158 |
ALPHATEC SPINE, INC. |
ZODIC POLYAXIAL SPINAL FIXATION SYSTEM |
07/03/2008 |
K132280 |
ALTUS PARTNERS |
ALTUS SPINE PEDICLE SCREW SYSTEM |
10/31/2013 |
K152324 |
BEIJING WEIGAO YAHUA ARTIFICIAL JOINT DEVELOPMENT CO. LTD. |
YAHUA Spinal System |
02/01/2016 |
K083178 |
BIOTECHNI AMERICA SPINE GROUP, INC. |
SOLAS ANATOMIX SPINAL SYSTEM |
02/23/2009 |
K072436 |
BK MEDITECH CO., LTD. |
MEGA SPINE SYSTEM |
11/01/2007 |
K042100 |
BLACKSTONE MEDICAL, INC. |
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR |
09/20/2004 |
K040034 |
BLACKSTONE MEDICAL, INC. |
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER |
02/11/2004 |
K080407 |
BLACKSTONE MEDICAL, INC. |
BLACKSTONE SFS PARALLEL ROD CONNECTORS |
03/13/2008 |
K013885 |
BLACKSTONE MEDICAL, INC. |
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS |
02/01/2002 |
K030862 |
BLACKSTONE MEDICAL, INC. |
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR |
04/17/2003 |
K003735 |
BLACKSTONE MEDICAL, INC. |
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR |
05/08/2001 |
K042514 |
BLACKSTONE MEDICAL, INC. |
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM |
10/07/2004 |
K122332 |
CAPTIVA SPINE |
TOWERLOX PEDICLE SCREW SYSTEM |
10/16/2012 |
K120292 |
CAPTIVA SPINE, INC |
CAPLOX II PEDICLE SCREW SYSTEM |
04/13/2012 |
K111115 |
CAPTIVA SPINE, INC |
CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM |
09/13/2011 |
K160731 |
CG BIO CO., LTD. |
LumFix Spinal Fixation Sytem |
10/04/2016 |
K150684 |
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD |
WASTON General Spinal System |
11/18/2015 |
K131522 |
CORE-NEXUS |
CORE PEDICLE SCREW SYSTEM |
08/09/2013 |
K120696 |
CORELINK LLC |
TIGER SPINE SYSTEM |
04/02/2012 |
K092076 |
CORENTEC CO., LTD |
AEGIS & AEGIS II SPINAL SYSTEM |
04/02/2010 |
K132644 |
CORENTEC CO., LTD |
LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU |
09/19/2013 |
K982154 |
DANEK MEDICAL, INC. |
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM |
07/13/1998 |
K984522 |
DANEK MEDICAL, INC. |
MODIFICATION OF TSRH SPINAL SYSTEM |
01/06/1999 |
K970599 |
DANEK MEDICAL, INC. |
TOWNLEY PEDICLE SCREW PLATING SYSTEM |
03/20/1998 |
K010972 |
DEPUY ACROMED |
ISOLA BAND CLAMP |
06/12/2001 |
K022285 |
DEPUY ACROMED |
MODIFICATION TO ISOLA SPINAL SYSTEM |
08/13/2002 |
K022190 |
DEPUY ACROMED |
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM |
07/24/2002 |
K010576 |
DEPUY ACROMED |
MONARCH SPINE SYSTEM |
05/23/2001 |
K013222 |
DEPUY ACROMED |
SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM |
11/07/2001 |
K030103 |
DEPUY ACROMED |
SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS |
02/05/2003 |
K984348 |
DEPUY MOTECH ACROMED |
TIMX LOW BACK SYSTEM |
01/20/1999 |
K984350 |
DEPUY MOTECH ACROMED |
VSP SYSTEM |
01/20/1999 |
K050675 |
DEPUY SPINE, INC. |
EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE |
04/11/2005 |
K103100 |
DEPUY SPINE, INC. |
MOUNTAINEER OCT SPINAL SYSTEM |
11/17/2010 |
K041203 |
DEPUY SPINE, INC. |
SUMMIT OCT SPINAL SYSTEM |
06/02/2004 |
K984378 |
DEPUY, INC. |
DEPUY ACROMED MOSS SPINAL SYSTEM |
12/30/1998 |
K100765 |
DIO MEDICAL CO., LTD. |
FIXPINE II SYSTEM |
07/19/2010 |
K151458 |
Double Medical Technology Inc |
Double Medical Universal Spine System |
08/22/2016 |
K991721 |
EBI ELECTRO BIOLOGY |
EBI OMEGA 21 SYSTEM |
08/13/1999 |
K031354 |
EBI, L.P. |
EBI OMEGA21 SPINAL FIXATION SYSTEM |
08/06/2003 |
K992920 |
EBI, L.P. |
EBI SPINELINK SYSTEM |
11/23/1999 |
K061978 |
EBI, L.P. |
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM |
08/11/2006 |
K001037 |
EBI, L.P. |
MODIFICATION TO EBI SPINELINK SYSTEM |
04/14/2000 |
K992333 |
ELECTRO-BIOLOGY, INC. |
EBI OMEGA 21 SYSTEM |
10/08/1999 |
K984027 |
ELECTRO-BIOLOGY, INC. |
EBI SPINELINK SYSTEM |
01/19/1999 |
K080075 |
ELITE SURGICAL SUPPLIES (PTY) LTD. |
MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM |
01/28/2008 |
K063453 |
ELITE SURGICAL SUPPLIES (PTY) LTD. |
VERTEFIX PEDICLE SCREW SPINAL SYSTEM |
08/30/2007 |
K100377 |
EMINENT SPINE |
DIAMONDBACK SPINAL SYSTEM |
04/22/2010 |
K000425 |
ENCORE ORTHOPEDICS, INC. |
ISOBAR SPINAL SYSTEM |
03/07/2000 |
K992738 |
ENCORE ORTHOPEDICS, INC. |
ISOBAR SPINAL SYSTEM |
11/08/1999 |
K012175 |
ENCORE ORTHOPEDICS, INC. |
PASS SPINAL SYSTEM |
07/31/2001 |
K013191 |
ENCORE ORTHOPEDICS, INC. |
PASS SPINAL SYSTEM |
10/24/2001 |
K013431 |
ENCORE ORTHOPEDICS, INC. |
PASS SPINAL SYSTEM |
11/15/2001 |
K000766 |
ENDIUS, INC. |
TRI-FIX SPINAL FIXATION SYSTEM |
06/01/2000 |
K010903 |
ENDIUS, INC. |
TRI-FIX SPINAL FIXATION SYSTEM |
06/06/2001 |
K010922 |
ENDIUS, INC. |
TRI-FIX SPINAL FIXATION SYSTEM |
06/06/2001 |
K013403 |
ENDIUS, INC. |
TRI-FIX SPINAL FIXATION SYSTEM |
11/14/2001 |
K110197 |
EXACTECH, INC. |
EXACTECH GIBRALT SPINAL SYSTEM |
07/15/2011 |
K020279 |
FOREX CORP. |
FOREX CORPORATION, OPTIMA, SPINAL SYSTEM |
06/20/2002 |
K022160 |
HOWMEDICA OSTEONICS |
XIA SPINAL SYSTEM |
08/01/2002 |
K000965 |
HOWMEDICA OSTEONICS CORP. |
MULTI-AXIAL CROSS (MAC) CONNECTOR |
05/11/2000 |
K993402 |
HOWMEDICA OSTEONICS CORP. |
OPUS SPINAL SYSTEM |
12/20/1999 |
K990059 |
HOWMEDICA OSTEONICS CORP. |
OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS |
01/28/1999 |
K032394 |
HOWMEDICA OSTEONICS CORP. |
STRYKER SPINE OASYS SYSTEM |
02/20/2004 |
K130958 |
INNOVATIVE SURGICAL DESIGNS |
TRUE SPINAL FIXATION SYSTEM |
10/17/2013 |
K011437 |
INTERPORE CROSS INTL. |
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS |
06/06/2001 |
K990057 |
INTERPORE CROSS INTL. |
SYNERGY ADJUSTABLE LENGTH ROD |
06/28/1999 |
K000876 |
INTERPORE CROSS INTL. |
SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP |
04/18/2000 |
K984578 |
INTERPORE CROSS INTL. |
SYNERGY D2 SPINAL IMPLANTS |
03/23/1999 |
K992369 |
INTERPORE CROSS INTL. |
SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22 |
10/13/1999 |
K000236 |
INTERPORE CROSS INTL. |
SYNERGY VLS CAP NUT MODELS 2206, 6102 |
02/16/2000 |
K071857 |
JEMO SPINE, LLC |
DELTA SPINAL FUSION SYSTEM |
08/08/2007 |
K092640 |
K2M, INC. |
CASPIAN SPINAL SYSTEM |
11/06/2009 |
K103440 |
K2M, INC. |
EVEREST SPINAL SYSTEM |
03/17/2011 |
K132361 |
K2M, INC. |
EVEREST SPINAL SYSTEM |
10/03/2013 |
K132757 |
K2M, INC. |
EVEREST SPINAL SYSTEM |
11/20/2013 |
K120656 |
K2M, INC. |
EVEREST SPINAL SYSTEM |
04/04/2012 |
K080792 |
K2M, INC. |
K2M COCR ROD |
04/08/2008 |
K110991 |
K2M, INC. |
MESA SPINAL SYSTEM (KEYSTONE RODS) |
08/02/2011 |
K072914 |
K2M, INC. |
NATURAL BRIDGE LP TRANSVERSE CONNECTORS |
01/03/2008 |
K070229 |
K2M, INC. |
RANGE SPINAL SYSTEM |
05/03/2007 |
K100851 |
K2M, INC. |
RANGE SPINAL SYSTEM |
08/02/2010 |
K112037 |
K2M, INC. |
RANGE SPINAL SYSTEM (MESA AND DENALI) |
10/06/2011 |
K112920 |
K2M, INC. |
RANGE SPINAL SYSTEM (MESA AND DENALI) |
12/21/2011 |
K120099 |
K2M, INC. |
RANGE SPINAL SYSTEM (MESA AND DENALI) |
05/18/2012 |
K120899 |
K2M, INC. |
RANGE SPINAL SYSTEM, UNIT ROD |
05/25/2012 |
K052398 |
K2M, LLC |
MESA SPINAL SYSTEM |
12/07/2005 |
K133103 |
K7 LLC |
AVERSION PEDICLE SCREW SYSTEM |
01/27/2014 |
K152098 |
Kisco International |
ODALYS Pedicle Screw System |
09/17/2015 |
K120538 |
KOREA BONE BANK CO., LTD |
PALLS M SPINAL SYSTEM |
03/23/2012 |
K120879 |
L & K BIOMED CO., LTD |
LEXUS CERVICAL FIXATION SYSTEM |
05/23/2012 |
K103414 |
L&K BIOMED CO.,LTD. |
VENUS CERVICAL SPINAL FIXATION SYSTEM |
07/22/2011 |
K071877 |
LANX, LLC |
LANX SPINAL FIXATION SYSTEM |
09/17/2007 |
K043484 |
LANX, LLC |
LANX SPINAL FIXATION SYSTEM |
05/16/2005 |
K093285 |
LANX, LLC |
MODIFICATION TO LANX SPINAL FIXATION SYSTEM |
12/10/2009 |
K043094 |
LDR SPINE USA |
EASYSPINE SYSTEM |
02/11/2005 |
K061017 |
LDR SPINE USA |
EASYSPINE SYSTEM |
08/10/2006 |
K100575 |
LDR SPINE USA |
LDR SPINE USA SPINE TUNE TL SPINE SYSTEM |
03/31/2010 |
K102331 |
LDR SPINE USA |
LDR SPINE USA SPINETUNE TL SPINAL SYSTEM |
10/15/2010 |
K063794 |
LDR SPINE USA |
MODIFICATION TO EASYSPINE SYSTEM |
01/24/2007 |
K113157 |
LIFE SPINE |
AILERON INTERSPINOUS FIXATION SYSTEM |
03/13/2012 |
K061600 |
LIFE SPINE |
ARX SPINAL SYSTEM |
08/22/2006 |
K080767 |
LIFE SPINE |
CONQUEST SPINAL SYSTEM |
05/21/2008 |
K100407 |
LIFE SPINE |
LIFE SPINE INTERSPINOUS FIXATION SYSTEM |
11/05/2010 |
K080502 |
LIFE SPINE |
MODIFICATION TO:PILOT SPINAL SYSTEM |
04/08/2008 |
K063601 |
LIFE SPINE |
PILOT SPINAL SYSTEM |
01/25/2007 |
K083865 |
LIFE SPINE |
PILOT SPINAL SYSTEM |
01/28/2009 |
K132788 |
MEDACTA INTERNATIONAL |
MYSPINE PEDICLE SCREW PLACEMENT GUIDES |
05/23/2014 |
K153273 |
Medacta International SA |
MySpine Pedicle Screw Placement Guides - LP |
06/29/2016 |
K062136 |
MEDICREA |
PASS 2 SPINAL SYSTEM |
10/06/2006 |
K112493 |
MEDICREA INTERNATIONAL |
PASS LP SPINAL SYSTEM |
11/21/2011 |
K140738 |
MEDICREA INTERNATIONAL |
PASS LP SPINAL SYSTEM |
11/04/2014 |
K150049 |
MEDICREA INTERNATIONAL |
PASS LP Spinal System |
02/10/2015 |
K070276 |
MEDICREA TECHNOLOGIES |
MODIFICATION TO PASSMED SPINAL SYSTEM |
09/21/2007 |
K082069 |
MEDICREA TECHNOLOGIES |
PASS 2 SPINAL SYSTEM |
10/03/2008 |
K083308 |
MEDICREA TECHNOLOGIES |
PASS LP SPINAL SYSTEM |
12/10/2008 |
K083810 |
MEDICREA TECHNOLOGIES |
PASS LP SPINAL SYSTEM |
07/31/2009 |
K100297 |
MEDICREA TECHNOLOGIES |
PASS LP SPINAL SYSTEM |
03/04/2010 |
K080099 |
MEDICREA TECHNOLOGIES |
PASS SPINAL SYSTEM |
04/09/2008 |
K032037 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) |
09/04/2003 |
K062606 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON SPINAL SYSTEM |
09/25/2006 |
K033271 |
MEDTRONIC SOFAMOR DANEK |
DYNALOK CLASSIC SPINAL SYSTEM |
11/06/2003 |
K031833 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
09/03/2003 |
K031888 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
06/27/2003 |
K041030 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
06/30/2004 |
K041118 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
05/28/2004 |
K041777 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
09/03/2004 |
K053483 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM |
01/05/2006 |
K040583 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO: CD HORIZON SPINAL SYSTEM |
03/31/2004 |
K042210 |
MEDTRONIC SOFAMOR DANEK |
MSD SILO SPINAL SYSTEM |
11/04/2004 |
K031655 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON SPINAL SYSTEM |
06/27/2003 |
K050981 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CD HORIZON SPINAL SYSTEM |
05/17/2005 |
K030932 |
MEDTRONIC SOFAMOR DANEK, INC. |
CD HORIZON SPINAL SYSTEM |
05/16/2003 |
K033495 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO EQUATION FIXATION SYSTEM |
12/03/2003 |
K042453 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO EQUATION FIXATION SYSTEM |
10/07/2004 |
K030840 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO HORIZON SPINAL SYSTEM |
05/15/2003 |
K000991 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO TSRH SPINAL SYSTEM |
04/18/2000 |
K011029 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO TSRH SPINAL SYSTEM |
06/05/2001 |
K011067 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO TSRH SPINAL SYSTEM |
05/04/2001 |
K021106 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO TSRH SPINAL SYSTEM |
05/03/2002 |
K022778 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO TSRH SPINAL SYSTEM |
09/18/2002 |
K062879 |
MEDTRONIC SOFAMOR DANEK, INC. |
TRAVERSE OCT SPINAL FIXATION SYSTEM |
12/22/2006 |
K031967 |
MEDTRONIC SOFAMOR DANEK, INC. |
TSRH SPINAL SYSTEM |
09/17/2003 |
K032578 |
MEDTRONIC SOFAMOR DANEK, INC. |
TSRH SPINAL SYSTEM |
09/17/2003 |
K093104 |
MEDYSSEY CO., LTD. |
MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM |
06/25/2010 |
K103147 |
MEDYSSEY CO., LTD. |
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM |
12/16/2010 |
K110284 |
MEDYSSEY CO., LTD. |
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM |
06/08/2011 |
K103272 |
MEDYSSEY CO., LTD. |
ZENIUS SPINAL SYSTEM |
12/29/2010 |
K110283 |
MEDYSSEY CO., LTD. |
ZENIUS SPINAL SYSTEM |
05/19/2011 |
K991862 |
MICOMED GMBH |
MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS) |
01/13/2000 |
K021275 |
MICOMED ORTHO GMBH |
MICOMED POSTERIOR DOUBLEROD SYSTEM |
07/18/2002 |
K022768 |
MICRON PRECISION ENGINEERING, INC. |
AMT POLYAXIAL PEDICLE SCREW |
11/13/2002 |
K143222 |
Mighty Oak Medical Inc |
FIREFLY Pedicle Screw Navigation Guide |
12/11/2015 |
K171497 |
Mikron Makina Sanayi Ticaret Co. Ltd. |
Mikron Spinal Fixation System |
10/12/2017 |
K130073 |
MIKRON MAKINA SANAYI VE TICARET LTD STI |
MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS |
12/16/2013 |
K141253 |
NEW ERA ORTHOPAEDICS, LLC |
NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM |
01/09/2015 |
K150647 |
New Era Orthopedics, LLC |
Polyscrew Pedicle Screw System |
04/08/2015 |
K132412 |
NEXXT SPINE LLC |
INERTIA MIS PEDICLE SCREW SYSTEM |
10/10/2013 |
K090984 |
NEXXT SPINE LLC |
INERTIA PEDICLE SCREW SYSTEM |
06/30/2009 |
K071435 |
NUVASIVE, INC. |
NUVASIVE OCT SYSTEM |
08/06/2007 |
K021379 |
ORTHO TEC LLC |
SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 |
05/31/2002 |
K033826 |
ORTHOPEDIC ALLIANCE LLC |
ORTHOPEDIC ALLIANCE SPINE SYSTEM |
07/01/2004 |
K040493 |
ORTHOPEDIC SCIENCES, INC |
OUTOLOGOUS SPINAL FIXATION SYSTEM |
09/03/2004 |
K040346 |
ORTHOTEC, L.L.C. |
MODIFICATION TO ORIA TOP CLIP SYSTEM |
03/12/2004 |
K030958 |
ORTHOTEC, L.L.C. |
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS |
11/20/2003 |
K011807 |
ORTHOTEC,LLC |
SCS CLARIS SPINAL SCREWS, TYPES V,G,E |
08/07/2001 |
K150294 |
Osteomed Implantes, LTDA |
DPZ Pedicular Fixation System |
06/05/2015 |
K990158 |
OSTEONICS CORP. |
OSTEONICS COMBINATION SCREW RING/BLOCKER |
02/01/1999 |
K071668 |
PARADIGM SPINE |
ORTHOBIOM SPINAL SYSTEM |
07/02/2008 |
K103102 |
PHYGEN, LLC |
LEUCADIA PEDICLE SCREW SYSTEM |
02/08/2011 |
K072187 |
PIONEER SURGICAL TECHNOLOGY |
PIONEER LOWTOP SPINAL ROD SYSTEM |
10/12/2007 |
K022908 |
PIONEER SURGICAL TECHNOLOGY |
POSTERIOR CABLE SCREW |
01/22/2004 |
K080026 |
PIONEER SURGICAL TECHNOLOGY |
QUANTUM-MIS CANNULATED SYSTEM |
01/28/2008 |
K024313 |
PISHARODI SURGICALS, INC. |
MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM |
08/29/2003 |
K141397 |
PRECISION SPINE, INC. |
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM |
06/26/2014 |
K081978 |
Reliance Medical Systems, LLC |
RELIANCE SPINAL SCREW SYSTEM |
03/26/2009 |
K110896 |
Reliance Medical Systems, LLC |
RELIANCE SPINAL SCREW SYSTEM |
01/20/2012 |
K152131 |
Reliance Medical Systems, LLC |
Reliance Spinal Screw System |
09/17/2015 |
K123521 |
Reliance Medical Systems, LLC |
RELIANCE SPINAL SCREW SYSTEM |
02/07/2013 |
K101682 |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
S 100 PEDICLE SCREW SYSTEM |
12/07/2010 |
K093833 |
ROBERT REID INC. |
KAPSS SPINAL SYSTEM |
10/15/2010 |
K113755 |
SAVANNAH TECHNOLOGIES LLC |
SAVANNAH TECHNOLOGIES SPINAL SYSTEM |
02/01/2012 |
K991326 |
SCIEN'TX USA INC. |
ISOBAR SEMI-RIGID SPINAL SYSTEM |
11/08/1999 |
K013440 |
SCIEN'TX USA INC. |
ISOBAR SPINAL SYSTEM |
11/16/2001 |
K051063 |
SCIENT'X |
POLYAXIAL HEMISPHERICAL SPINAL SCREWS |
05/23/2005 |
K062912 |
SCIENT'X |
SCIENT'X SPINAL SYSTEM |
02/05/2007 |
K032739 |
SEASPINE |
UCR SPINAL SYSTEM |
11/20/2003 |
K031381 |
SEASPINE |
UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS |
07/30/2003 |
K062934 |
SEASPINE, INC. |
SIERRA |
11/16/2006 |
K160320 |
Shandong Weigao Orthopaedic Device Co., Ltd |
Premier |
04/01/2016 |
K051704 |
SHOWA IKA KOHGYO CO.,LTD. |
MYKRES SPINAL SYSTEM |
07/03/2006 |
K071074 |
SHOWA IKA KOHGYO CO.,LTD. |
MYKRES SPINAL SYSTEM |
07/02/2008 |
K031455 |
SIGNUS MEDICAL LLC. |
CONKLUSION PEDICLE SCREW SYSTEM |
10/22/2003 |
K112611 |
SINTEA PLASTEK, LLC |
SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS |
04/25/2012 |
K992928 |
SOFAMOR DANEK USA,INC. |
CD HORIZON SPINAL SYSTEM |
09/21/1999 |
K980184 |
SOFAMOR DANEK USA,INC. |
CD SPINAL SYSTEM |
12/18/1998 |
K983672 |
SOFAMOR DANEK USA,INC. |
DYNA-LOK SPINAL SYSTEM |
12/16/1998 |
K982686 |
SOFAMOR DANEK USA,INC. |
MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM |
08/07/1998 |
K982990 |
SOFAMOR DANEK USA,INC. |
TSRH SPINAL SYSTEM |
10/21/1998 |
K121615 |
SOLCO BIOMEDICAL CO., LTD. |
4CIS VANE SPINE SYSTEM |
08/15/2012 |
K081145 |
SOLCO BIOMEDICAL CO., LTD. |
MODIFICATION TO 4CIS VANE SPINE SYSTEM |
11/05/2008 |
K010563 |
SPINAL CONCEPTS, INC. |
END-TO-END AND SIDE-BY-SIDE CONNECTORS |
05/25/2001 |
K023644 |
SPINAL CONCEPTS, INC. |
MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM |
11/25/2002 |
K983258 |
SPINAL CONCEPTS, INC. |
MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM |
10/21/1998 |
K983260 |
SPINAL CONCEPTS, INC. |
MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM |
10/21/1998 |
K031985 |
SPINAL CONCEPTS, INC. |
SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM |
09/11/2003 |
K032219 |
SPINAL INNOVATIONS, INC. |
REVOLUTION SPINAL FIXATION SYSTEM |
12/19/2003 |
K090033 |
SPINAL USA |
MODIFICATION TO: PSS SYSTEM |
05/06/2009 |
K092128 |
SPINAL USA |
MODIFICATION TO: PSS SYSTEM |
09/14/2009 |
K071438 |
SPINAL USA |
PSS SYSTEM |
08/21/2007 |
K073240 |
SPINAL USA |
PSS SYSTEM |
03/20/2008 |
K121172 |
SPINAL USA |
REFORM PEDICLE SCREW SYSTEM |
08/08/2012 |
K131343 |
SPINAL USA |
REFORM PEDICLE SCREW SYSTEM |
07/24/2013 |
K130279 |
SPINAL USA |
REFORM PEDICLE SCREW SYSTEM |
06/20/2013 |
K122931 |
SPINAL USA |
S-LOK PSS SYSTEM |
11/20/2012 |
K141835 |
SPINE ART |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS |
09/10/2014 |
K033947 |
SPINE NEXT AMERICA |
SHIRAZ POSTERIOR SYSTEM |
03/04/2004 |
K033772 |
SPINE NEXT AMERICA |
SHIRAZ-JAVA SPINAL FIXATION SYSTEM |
01/27/2004 |
K021510 |
SPINE VISION, INC |
UNI-T UNI-THREAD SPINAL SYSTEM |
08/01/2002 |
K052406 |
SPINE VISION, INC |
UNI-THREAD SPINAL SYSTEM |
11/07/2005 |
K070245 |
SPINE WAVE, INC. |
CAPSURE PEDICLE SCREW SYSTEM |
04/05/2007 |
K081228 |
SPINE WAVE, INC. |
CAPSURE PS (R) SPINE SYSTEM |
05/12/2008 |
K132154 |
SPINE WAVE, INC. |
CAPSURE PS SYSTEM |
08/09/2013 |
K083743 |
SPINE WAVE, INC. |
CAPSURE PS SYSTEM |
01/13/2009 |
K120646 |
SPINE WAVE, INC. |
CAPSURE(R) PS SYSTEM |
06/07/2012 |
K111913 |
SPINE WAVE, INC. |
CAPSURE(R) PS SYSTEM |
08/31/2011 |
K122233 |
SPINE WAVE, INC. |
CAPSURE(R) PS SYSTEM |
10/11/2012 |
K083353 |
SPINE WAVE, INC. |
CAPSURE(R) PS SYSTEM |
12/11/2008 |
K160003 |
SPINE WAVE, INC. |
Sniper (R) Spine System |
02/26/2016 |
K151813 |
SPINE WAVE, INC. |
Sniper Spine System |
07/31/2015 |
K152174 |
SPINE WAVE, INC. |
Sniper Spine System |
08/31/2015 |
K102995 |
SPINE360 |
TALON SPINAL SYSTEM |
02/02/2011 |
K093170 |
SPINEART |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
11/04/2009 |
K093936 |
SPINEART |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
03/11/2010 |
K111127 |
SPINEART |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
08/11/2011 |
K112108 |
SPINEART |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
08/19/2011 |
K092420 |
SPINEFRONTIER, INC. |
KRD1 PEDICLE SCREW SYSTEM |
11/19/2009 |
K160124 |
SpineVision S.A. |
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System |
04/04/2016 |
K022271 |
SPINEVISION, INC. |
PLUS PIVOT LINK UNIVERSAL SYSTEM |
09/23/2002 |
K033508 |
SPINEVISION, INC. |
PLUS PIVOT LINK UNIVERSAL SYSTEM |
01/27/2004 |
K032398 |
SPINEVISION, INC. |
PLUS PIVOT LINK UNIVERSAL SYSTEM |
10/31/2003 |
K013301 |
SPINEVISION, INC. |
UNI-T SPINAL SYSTEM |
02/13/2002 |
K130302 |
SPINEVISION, S.A. |
SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT |
07/30/2013 |
K062853 |
STRYKER SPINE |
MODIFICATION TO STRYKER SPINE OASYS SYSTEM |
10/24/2006 |
K080143 |
STRYKER SPINE |
MODIFICATION TO STRYKER SPINE OASYS SYSTEM |
02/14/2008 |
K052317 |
STRYKER SPINE |
MODIFICATION TO: STRYKER SPINE OASYS SYSTEM |
09/21/2005 |
K052761 |
STRYKER SPINE |
MODIFICATION TO: XIA 4.5 SPINAL SYSTEM |
10/11/2005 |
K052971 |
STRYKER SPINE |
STRYKER SPINE TRIO SPINAL FIXATION SYSTEM |
11/16/2005 |
K062698 |
STRYKER SPINE |
TRIO + SPINAL SYSTEM |
10/11/2006 |
K053115 |
STRYKER SPINE |
XIA SPINAL SYSTEM |
12/06/2005 |
K992276 |
SULZER SPINE-TECH |
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM |
10/01/1999 |
K151592 |
SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD. |
Gemmed pedicle screw spinal system |
09/24/2015 |
K010108 |
SYNTHES |
USS-LINE EXTENSION |
06/06/2001 |
K030377 |
SYNTHES (USA) |
MODIFICATION TO SYNTHES CERVIFIX SYSTEM |
03/06/2003 |
K010658 |
SYNTHES (USA) |
MODIFIED USS FRACTURE SYSTEM |
06/04/2001 |
K994121 |
SYNTHES (USA) |
SMALL STATURE USS |
10/17/2000 |
K020517 |
SYNTHES (USA) |
SYNTHES DUAL-OPENING USS |
04/15/2002 |
K022949 |
SYNTHES (USA) |
SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS |
03/24/2003 |
K990745 |
SYNTHES SPINE |
MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM |
03/30/1999 |
K000450 |
SYNTHES SPINE |
MODIFICATION TO SYNTHES USS |
03/10/2000 |
K982987 |
SYNTHES SPINE |
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM |
10/21/1998 |
K984612 |
SYNTHES SPINE |
SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM |
01/19/1999 |
K113149 |
SYNTHES SPINE |
SYNTHES USS CONNECTORS |
02/01/2012 |
K070573 |
SYNTHES SPINE CO.LP |
SYNAPSE SYSTEM |
06/08/2007 |
K072434 |
SYNTHES SPINE CO.LP |
SYNTHES OC FUSION AND SYNAPSE SYSTEMS |
01/10/2008 |
K063708 |
TAE YEON MEDICAL CO., LTD |
4S SPINAL SYSTEM |
04/24/2007 |
K071743 |
THE 4TH COLUMN, LLC |
PILLAR PEDICLE SCREW SYSTEM |
07/06/2007 |
K083073 |
THEKEN SPINE LLC |
THEKEN ATOLL CERVICO-THORACIC SYSTEM |
03/13/2009 |
K083863 |
THEKEN SPINE LLC |
THEKEN ATOLL OCT SPINAL SYSTEM |
03/27/2009 |
K140229 |
TIANJIN WALKMAN BIOMATERIAL CO., LTD. |
GENERAL SPINAL SYSTEM |
04/29/2014 |
K082617 |
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. |
TRAUSON GENERAL SPINAL SYSTEM (GSS) |
01/15/2009 |
K081790 |
TRINITY ORTHOPEDICS, LLC |
MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM |
07/24/2008 |
K070295 |
TRINITY ORTHOPEDICS, LLC |
SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM |
05/21/2007 |
K024096 |
U&I CORP., AMERICA |
OPTIMA, SPINAL SYSTEM |
03/12/2003 |
K080841 |
ULRICH GMBH & CO. KG |
COSMIC SYSTEM |
07/23/2008 |
K081597 |
VERTEBRON, INC. |
MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM |
07/02/2008 |
K033352 |
VERTEBRON, INC. |
VERTEBRON PSS PEDICLE SCREW SYSTEM |
02/25/2004 |
K073143 |
VERTIFLEX, INC. |
MODIFIED VERTIFLEX SPINAL SCREW SYSTEM |
04/07/2008 |
K122163 |
X-SPINE SYSTEMS, INC |
CERTEX SPINAL IMPLANT SYSTEM |
10/31/2012 |
K052847 |
X-SPINE SYSTEMS, INC. |
CAPLESS PEDICLE SCREW SYSTEM |
12/12/2005 |
K152132 |
X-spine Systems, Inc. |
X-spine Pedicle Screw System |
09/25/2015 |
K112484 |
ZAVATION LLC |
ZAVATION SPINAL SYSTEM |
11/22/2011 |
K071880 |
ZIMMER SPINE, INC |
Optima ZS Transition Screw |
10/05/2007 |