FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K101374 |
AAXTER CO., LTD |
AAXTER A3 POSTERIOR SPINAL SYSTEM |
03/16/2011 |
K073531 |
ACCELERATED INNOVATION, LLC |
ACCIN PEDICLE SCREW SYSTEM |
02/04/2008 |
K001044 |
ACME SPINE, LLC. |
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM |
11/03/2000 |
K964007 |
ACROMED CORP. |
ACROMED CABLE/WIRE PEDICLE SCREW |
12/16/1996 |
K965102 |
ACROMED CORP. |
ACROMED PEDICLE SCREW |
05/08/1997 |
K981274 |
ACROMED CORP. |
ACROMED TIMX PLATE BASED LOW BACK SYSTEM |
04/29/1998 |
K970950 |
ACROMED CORP. |
EASY ROD |
06/03/1997 |
K952236 |
ACROMED CORP. |
ISOLA SYSTEM |
01/22/1996 |
K962645 |
ACROMED CORP. |
ISOLA TWISTER CONNECTOR |
10/22/1996 |
K965046 |
ACROMED CORP. |
ISOLA TWISTER CONNECTOR |
03/14/1997 |
K981113 |
ACROMED CORP. |
PEDIATRIC PRC |
05/29/1998 |
K981714 |
ACROMED CORP. |
TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM |
06/30/1998 |
K103573 |
ADVANCED MEDICAL TECHNOLOGIES |
ARTS2 SPINAL FIXATION SYSTEM |
12/28/2011 |
K970285 |
AESCULAP, INC. |
AESUCLAP SOCON SPINAL SYSTEM |
06/25/1997 |
K993551 |
AESCULAP, INC. |
SOCON SPINAL SYSTEM |
01/13/2000 |
K003463 |
AESCULAP, INC. |
SOCON SPINAL SYSTEM |
04/11/2001 |
K083826 |
ALLEZ SPINE, LLC |
LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM |
01/22/2009 |
K100956 |
ALLURE SPINE L.L.C. |
SPONDY SPINAL FIXATION SYSTEM |
07/09/2010 |
K020356 |
ALPHATEC MFG., INC. |
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM |
07/23/2002 |
K090228 |
ALPHATEC SPINE, INC. |
ROC LUMBAR PLATING SYSTEM |
04/29/2009 |
K071890 |
ALPHATEC SPINE, INC. |
ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM |
11/09/2007 |
K061321 |
ALPHATEC SPINE, INC. |
ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX |
07/07/2006 |
K050078 |
ALPHATEC/NEXMED |
ROC LUMBAR PLATING SYSTEM |
02/18/2005 |
K051286 |
ALPHATEC/NEXMED |
ZODIAC SPINAL FIXATION SYSTEM |
06/17/2005 |
K051044 |
ALTIVA CORP. |
ARCTEC SEMIRIGID PLATING SYSTEM |
10/07/2005 |
K053070 |
ALTIVA CORP. |
CONTOUR II SPINAL SYSTEM |
02/13/2006 |
K051216 |
ALTIVA CORP. |
HYDRALOK SYSTEM |
07/19/2005 |
K102636 |
APOLLO SPINE, INC. |
ZENITH PEDICLE SYSTEM |
03/03/2011 |
K061162 |
APPLIED SPINE TECHNOLOGIES, INC. |
BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 |
07/26/2006 |
K080876 |
BK MEDITECH CO., LTD. |
DVX SPINE SYSTEM |
06/04/2008 |
K090424 |
BK MEDITECH CO., LTD. |
DVX SPINE SYSTEM |
05/14/2009 |
K994217 |
BLACKSTONE MEDICAL, INC. |
BLACKSTONE SPINAL FIXATION SYSTEM |
02/28/2000 |
K020674 |
BLACKSTONE MEDICAL, INC. |
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW |
04/03/2002 |
K030581 |
BLACKSTONE MEDICAL, INC. |
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) |
06/26/2003 |
K120353 |
BM KOREA CO., LTD. |
SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM |
05/09/2012 |
K950999 |
BUCKMAN CO., INC. |
KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS |
01/25/1996 |
K950099 |
BUCKMAN CO., INC. |
SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM |
01/16/1997 |
K960451 |
BUCKMAN CO., INC. |
WEBB-MORLEY SPINE SYSTEM |
04/18/1996 |
K161151 |
CANWELL MEDICAL CO., LTD. |
Spinal fixation system |
09/21/2016 |
K131538 |
CAPTIVA SPINE |
CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM |
08/08/2013 |
K151116 |
CAPTIVA SPINE |
CapLOX II/TowerLOX Pedicle Screw System |
06/26/2015 |
K160020 |
Captiva Spine |
Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System |
03/02/2016 |
K134011 |
CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD |
GENERAL SPINAL SYSTEM |
09/03/2014 |
K143013 |
Changzhou Dingjian Medical Appliance Co., Ltd |
Spinal Inner Fixation System |
12/11/2015 |
K111690 |
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. |
DEVINE SPINAL SYSTEM |
11/22/2011 |
K142655 |
CHIN BONE TECHNIQUE CORP |
CB PROT II Posterior Spinal System |
01/26/2015 |
K051089 |
CO-LIGNE AG |
GII SPINAL FIXATION SYSTEM |
10/26/2005 |
K032604 |
CO-LIGNE AG |
GII SPINAL FIXATION SYSTEM |
01/20/2004 |
K083567 |
CO-LIGNE AG |
GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW |
09/14/2009 |
K110321 |
CORELINK, LLC |
TIGER SPINE SYSTEM |
05/25/2011 |
K973425 |
CORIN U.S.A. |
THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM |
02/27/1998 |
K990657 |
CORIN U.S.A. |
TRIFIX PEDICLE SPINAL SCREW ASSEMBLY |
03/26/1999 |
K010776 |
CORIN U.S.A. |
TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS |
04/06/2001 |
K973836 |
CROSS MEDICAL PRODUCTS, INC. |
SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM |
03/05/1998 |
K974749 |
CROSS MEDICAL PRODUCTS, INC. |
SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS |
03/13/1998 |
K001668 |
D.K.M. CO.,LTD. |
GLOBAL SPINAL FIXATION SYSTEM |
10/19/2000 |
K993810 |
DANEK MEDICAL, INC. |
CD HORIZON SPINAL SYSTEM |
02/03/2000 |
K991528 |
DANEK MEDICAL, INC. |
MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR |
05/28/1999 |
K943827 |
DANEK MEDICAL, INC. |
SPINE FIXATION |
02/14/1996 |
K021879 |
DEPUY ACROMED |
CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) |
06/26/2002 |
K021880 |
DEPUY ACROMED |
CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM) |
06/26/2002 |
K012971 |
DEPUY ACROMED |
ISOLA SPINAL SYSTEMS |
10/05/2001 |
K023438 |
DEPUY ACROMED |
MODIFICATION TO MONARCH SPINE SYSTEM |
11/13/2002 |
K030383 |
DEPUY ACROMED |
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS |
02/26/2003 |
K011182 |
DEPUY ACROMED |
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS |
05/16/2001 |
K013294 |
DEPUY ACROMED |
MONARCH SPINAL SYSTEMS |
10/09/2001 |
K021335 |
DEPUY ACROMED |
MONARCH SPINE SYSTEM |
07/11/2002 |
K024348 |
DEPUY ACROMED |
MONARCH SPINE SYSTEM |
01/28/2003 |
K021148 |
DEPUY ACROMED |
MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD |
05/08/2002 |
K010742 |
DEPUY ACROMED |
MOSS MIAMI 5.5MM TITANIUM PIN NUT |
04/12/2001 |
K013296 |
DEPUY ACROMED |
MOSS MIAMI SPINAL SYSTEMS |
10/09/2001 |
K013295 |
DEPUY ACROMED |
TIMX SPINAL SYSTEMS |
10/09/2001 |
K980447 |
DEPUY ORTHOPAEDICS, INC. |
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM |
04/14/1998 |
K062174 |
DEPUY SPINE, INC. |
MODIFICATION TO EXPEDIUM SPINE SYSTEM |
11/02/2006 |
K080828 |
DEPUY SPINE, INC. |
MOUNTAINEER OCT SPINAL SYSTEM |
06/27/2008 |
K062196 |
DEPUY SPINE, INC. |
SFX SNAP-FIT CROSS CONNECTOR |
09/11/2006 |
K972568 |
DEPUY, INC. |
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM |
09/19/1997 |
K953915 |
DEPUY, INC. |
MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE) |
02/15/1996 |
K111362 |
DIO MEDICAL CO., LTD. |
REXIOUS SPINAL FIXATION SYSTEM |
07/21/2011 |
K973683 |
EBI ELECTRO BIOLOGY |
OMEGA 21 SYSTEM |
12/24/1997 |
K061441 |
EBI, L.P. |
EBI 5.5 HELICAL FLANGE SPINAL SYSTEM |
07/25/2006 |
K020681 |
EBI, L.P. |
EBI OMEGA21 SPINAL FIXATION SYSTEM |
04/03/2002 |
K031423 |
EBI, L.P. |
EBI P148 SPINAL FIXATION SYSTEM |
06/27/2003 |
K014137 |
EBI, L.P. |
MODIFICATION TO EBI OMEGA 21 SYSTEM |
01/16/2002 |
K023204 |
EBI, L.P. |
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM |
10/18/2002 |
K003764 |
EBI, L.P. |
MODIFICATION TO EBI SPINELINK SYSTEM |
01/02/2001 |
K964533 |
ELECTRO-BIOLOGY, INC. |
EBI SPINELINK SYSTEM |
04/09/1997 |
K971970 |
ELECTRO-BIOLOGY, INC. |
EBI SPINELINK SYSTEM |
08/20/1997 |
K960107 |
ENCORE ORTHOPEDICS, INC. |
DDS SPINAL SYSTEM |
05/03/1996 |
K000020 |
ENCORE ORTHOPEDICS, INC. |
MODIFICATION TO ISOBAR SPINAL SYSTEM |
02/03/2000 |
K001024 |
ENCORE ORTHOPEDICS, INC. |
PASS SPINAL SYSTEM |
05/23/2000 |
K021881 |
ENDIUS, INC. |
ENDIUS TITLE SPINAL FIXATION SYSTEM |
07/29/2002 |
K001627 |
ENDIUS, INC. |
TRIFIX SPINAL FIXATION SYSTEM |
06/03/2000 |
K010535 |
ENDIUS, INC. |
TRIFIX SPINAL FIXATION SYSTEM |
03/19/2001 |
K122814 |
EVEREST SPINE, LLC |
GALLEON PEDICLE SCREW SYSTEM |
12/03/2012 |
K102870 |
EXACTECH, INC. |
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM |
01/21/2011 |
K081041 |
G SURGICAL CO., LTD. |
GPS, G SURGICAL PEDICLE SYSTEM |
06/27/2008 |
K040442 |
GLOBUS MEDICAL, INC. |
PROTEX STABILIZATION SYSTEM |
05/20/2004 |
K123487 |
GOLD STANDARD ORTHOPAEDICS, LLC |
GSO GS1 CANNULATED SCREW SYSTEM |
03/11/2013 |
K053573 |
GS MEDICAL CO., LTD. |
GSS PEDICLE SCREW SYSTEM |
03/08/2006 |
K012027 |
HOWMEDICA OSTEONICS |
MODIFICATION TO XIA SPINE SYSTEM |
07/20/2001 |
K032855 |
HOWMEDICA OSTEONICS |
STRYKER SPINE MAPS SYSTEM |
12/10/2003 |
K014229 |
HOWMEDICA OSTEONICS CORP. |
MODIFICATION TO OPUS SPINAL SYSTEM |
01/25/2002 |
K010845 |
HOWMEDICA OSTEONICS CORP. |
MODIFICATION TO OSTEONICS SPINAL SYSTEM |
04/18/2001 |
K013688 |
HOWMEDICA OSTEONICS CORP. |
MODIFICATION TO XIA SPINAL SYSTEM |
12/05/2001 |
K003490 |
HOWMEDICA OSTEONICS CORP. |
OPUS ROD FIXATION SYSTEM |
12/08/2000 |
K020293 |
HOWMEDICA OSTEONICS CORP. |
OSTEONICS SPINAL SYSTEM |
02/14/2002 |
K991055 |
HOWMEDICA OSTEONICS CORP. |
OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM |
08/27/1999 |
K001319 |
HOWMEDICA OSTEONICS CORP. |
XIA SPINE SYSTEM HOOKS |
05/23/2000 |
K151362 |
HUNG CHUN BIO-S CO., LTD. |
HC Spinal System |
05/05/2016 |
K021623 |
IAME, INC. |
UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS |
09/10/2002 |
K111995 |
IMPLANOVA CO. LTD |
XINGTM SPINE SYSTEM |
12/12/2011 |
K162143 |
INNOVASIS, INC. |
FixxSure« X-Link |
09/23/2016 |
K133690 |
INNOVATIVE SURGICAL DESIGNS |
TRUE SPINAL FUSSION SYSTEM |
05/07/2014 |
K993503 |
INTERNATIONAL ADVANCED MEDICAL ENTERPRISES, INC. |
HAIDER-UCR SPINAL SYSTEM |
04/14/2000 |
K993808 |
INTERPORE CROSS INTL. |
SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220 |
12/06/1999 |
K962757 |
J.B.S., S.A. |
J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP |
09/25/1996 |
K953881 |
J.B.S., S.A. |
SPINE SYSTEM SACRAL PLATE |
02/21/1996 |
K142957 |
JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD. |
Ideal pedicle screw spinal system |
01/30/2015 |
K080611 |
K2M, INC. |
MESA SPINAL SYSTEM |
03/04/2009 |
K121016 |
K2M, INC. |
RANGE SPINAL SYSTEM (MESA AND DENALI) |
06/27/2012 |
K081381 |
K2M, INC. |
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS |
06/13/2008 |
K140678 |
KALITEC DIRECT, LLC |
COSMOLOCK PEDICLE SCREW SYSTEM |
06/19/2014 |
K111370 |
KALITEC DIRECT, LLC |
ODALYS PEDICLE SCREW SYSTEM |
09/21/2011 |
K980852 |
KAREN E. WARDEN, M.E.B.E. |
GII SPINAL FIXATION SYSTEM |
05/01/1998 |
K082509 |
KOREA BONE BANK CO., LTD |
EOS SPINAL SYSTEM |
12/15/2008 |
K102574 |
KOREA BONE BANK CO., LTD |
PALLA M SPINAL SYSTEM |
03/07/2011 |
K100373 |
KYUNGWON MEDICAL CO., LTD. |
TYCHE PEDICLE SCREW SYSTEM |
06/30/2010 |
K100706 |
L & K BIOMED CO., LTD |
VENUS BASIC SPINAL FIXATION SYSTEM |
07/22/2010 |
K103085 |
L&K BIOMED CO., LTD |
VENUS BASIC SPINAL FIXATION SYSTEM |
02/09/2011 |
K162801 |
L&K BIOMED CO., LTD. |
CastleLoc Spinal Fixation System |
11/03/2016 |
K083581 |
LANX, INC. |
LANX SPINAL FIXATION SYSTEM |
04/07/2009 |
K120760 |
LDR SPINE USA INC. |
LDR SPINE SPINETUNE TL SPINAL SYSTEM |
06/27/2012 |
K061364 |
LIFE SPINE |
PILOT POSTERIOR LUMBAR PLATING SYSTEM |
09/05/2006 |
K123476 |
LSK BIOPARTNERS, INC. |
MEGA 5.5 SPINE SYSTEM |
01/08/2013 |
K101446 |
MAZOR SURGICAL TECHNOLOGIES LTD. |
EMERALD SPINAL SYSTEM |
01/20/2011 |
K051697 |
MEDICAL DEVICE ADVISORY DEVELOPMENT GROUP |
SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM |
09/21/2005 |
K110497 |
MEDICREA INTERNATIONAL |
PASS LP SPINAL SYSTEM |
09/26/2011 |
K142798 |
MEDICREA INTERNATIONAL S.A. |
PASS LP Spinal System |
03/25/2015 |
K070530 |
MEDICREA TECHNOLOGIES |
MODIFICATION TO PASSMED SPINAL SYSTEM |
10/18/2007 |
K082577 |
MEDICREA TECHNOLOGIES |
PASS LP SPINAL SYSTEM |
10/03/2008 |
K061915 |
MEDTRONIC SOFAMOR DANEK |
CD HORIZON SPINAL SYSTEM |
07/25/2006 |
K033322 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
12/15/2003 |
K034056 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
04/21/2004 |
K043343 |
MEDTRONIC SOFAMOR DANEK |
MODIFICATION TO: CD HORIZON SPINAL SYSTEM |
12/28/2004 |
K000094 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
02/08/2000 |
K001066 |
MEDTRONIC SOFAMOR DANEK, INC. |
CD HORIZON ECLIPSE |
06/22/2000 |
K000641 |
MEDTRONIC SOFAMOR DANEK, INC. |
CD HORIZON SPINAL SYSTEM |
12/22/2000 |
K001255 |
MEDTRONIC SOFAMOR DANEK, INC. |
CD HORIZON SPINAL SYSTEM |
07/11/2000 |
K010249 |
MEDTRONIC SOFAMOR DANEK, INC. |
CD HORIZON SPINAL SYSTEM |
02/23/2001 |
K020247 |
MEDTRONIC SOFAMOR DANEK, INC. |
COLORADO 2 SPINAL SYSTEM |
07/22/2002 |
K013962 |
MEDTRONIC SOFAMOR DANEK, INC. |
EQUATION FIXATION SYSTEM |
06/20/2002 |
K002399 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
09/27/2000 |
K040072 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
02/12/2004 |
K000453 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO CD SPINAL SYSTEM |
03/10/2000 |
K000476 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO CD SPINAL SYSTEM |
03/10/2000 |
K014076 |
MEDTRONIC SOFAMOR DANEK, INC. |
MODIFICATION TO TSRH SPINAL SYSTEM |
12/27/2001 |
K010720 |
MEDTRONIC SOFAMOR DANEK, INC. |
TSRH SPINAL SYSTEM |
04/11/2001 |
K020699 |
MEDTRONIC SOFAMOR DANEK, INC. |
TSRH SPINAL SYSTEM |
05/28/2002 |
K081153 |
MEDYSSEY CO., LTD. |
NOVEL SPINAL SYSTEM |
01/30/2009 |
K053623 |
N-SPINE, INC. |
NFIX FUSION SYSTEM |
07/12/2006 |
K033512 |
NAS MEDICAL TECHNOLOGIES, INC. |
PROCYON SPINAL SYSTEM |
06/03/2004 |
K133287 |
NEXUS SPINE, LLC |
PRESSON SPINAL FIXATION SYSTEM |
02/25/2014 |
K101278 |
NEXXT SPINE LLC |
INERTIA PEDICLE SCREW SYSTEM |
12/20/2010 |
K141376 |
NEXXT SPINE LLC |
INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS |
06/26/2014 |
K092011 |
NORM TIBBI URUNLER ITHALAT IHRACAT SANAYI VE TICAR |
NORM SPINAL SYSTEM |
10/28/2009 |
K062317 |
NUVASIVE, INC. |
MODIFICATION TO NUVASIVE SPHERX II SYSTEM |
09/01/2006 |
K061778 |
NUVASIVE, INC. |
NUVASIVE SPHERX II SYSTEM |
07/18/2006 |
K060225 |
NUVASIVE, INC. |
NUVASIVE SPHERX SYSTEM |
04/12/2006 |
K033546 |
NUVASIVE, INC. |
NUVASIVE SPINAL SYSTEM |
04/12/2004 |
K051959 |
NV CORMED |
NV CORMED SOLAS SPINAL SYSTEM |
10/12/2005 |
K061524 |
ORTHO DEVELOPMENT CORP. |
ISS INTEGRATED SPINE SYSTEM |
09/26/2006 |
K994288 |
ORTHOTEC, L.L.C. |
5.0MM SPINAL SCREWS |
04/10/2000 |
K010369 |
ORTHOTEC, L.L.C. |
CLARIS PLATE SYSTEM |
05/08/2001 |
K993926 |
ORTHOTEC, L.L.C. |
OMNIAXIAL CONNECTOR |
12/17/1999 |
K023378 |
ORTHOTEC, L.L.C. |
ORIA CLARIS |
06/27/2003 |
K023994 |
ORTHOTEC, L.L.C. |
ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ |
02/05/2003 |
K003733 |
ORTHOTEC, L.L.C. |
SCS CLOSED SCREW |
05/29/2001 |
K131810 |
OSSEUS FUSION SYSTEMS, LLC |
OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM |
08/08/2013 |
K964544 |
OSTEONICS CORP. |
OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY |
02/11/1997 |
K983152 |
OSTEONICS CORP. |
OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS |
09/25/1998 |
K984302 |
OSTEONICS CORP. |
OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS |
12/18/1998 |
K964304 |
OSTEONICS CORP. |
OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY |
01/17/1997 |
K003384 |
OSTEOTECH, INC. |
VERSALINK TITANIUM ROD-TO-ROD COUPLERS |
11/24/2000 |
K083077 |
OTIS BIOTECH CO., LTD |
ULC SPINAL PEDICLE SCREW SYSTEM |
10/26/2009 |
K120491 |
PARADIGM SPINE, LLC |
DSS STABILIZATION SYSTEM-RIGID |
05/09/2012 |
K093771 |
PIONEER SURGICAL TECHNOLOGY |
QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM |
08/10/2010 |
K014302 |
PISHARODI SURGICALS, INC. |
UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM |
03/29/2002 |
K162066 |
Reliance Medical Systems, LLC |
Reliance Spinal Screw System |
12/02/2016 |
K111940 |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
S 100 PEDICLE SCREW SYSTEM |
05/15/2012 |
K150283 |
REPUBLIC SPINE, LLC |
Republic Spine Dark Star Spinal System |
04/29/2015 |
K090477 |
SANACOR |
ALPINE PEDICLE SCREW SYSTEM |
07/27/2009 |
K070933 |
SANACOR |
LOWTOP PEDICLE SCREW SYSTEM |
06/13/2007 |
K013444 |
SCIEN'TX USA INC. |
ISOBAR SPINAL SYSTEM |
11/16/2001 |
K990118 |
SCIEN'TX USA INC. |
ISOBAR SPINAL SYSTEM |
03/22/1999 |
K990721 |
SCIEN'TX USA INC. |
ISOLOCK SPINAL SYSTEM |
05/27/1999 |
K020245 |
SCIEN'TX USA INC. |
MODIFICATION TO ISOBAR SPINAL SYSTEM |
02/01/2002 |
K040747 |
SCIENT'X |
ALADYN RIGID SPINE PLATE |
06/17/2004 |
K042964 |
SCIENT'X |
MX MONOAXIAL PEDICLE SCREW |
11/22/2004 |
K043001 |
SCIENT'X |
MX POLYAXIAL PEDICLE SCREW |
12/01/2004 |
K031290 |
SCIENT'X USA, INC. |
MODIFICATION TO EASYS TRANSVERSE CONNECTION |
05/13/2003 |
K061577 |
SIGNUS MEDIZINTECHNIK GMBH |
OVALTWIST PEDICLE SCREW SYSTEM |
09/14/2006 |
K081631 |
SINTEA BIOTECH, INC. |
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS |
07/18/2008 |
K020085 |
SINTEA BIOTECH, INC. |
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X |
12/10/2002 |
K140787 |
SINTEA PLUSTEK, LLC |
PLS (POSTERIOR LUMBAR SYSTEM) |
05/30/2014 |
K962784 |
SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
ULTIUM SPINAL PLATING SYSTEM |
10/02/1996 |
K991460 |
SOFAMOR DANEK |
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM |
05/19/1999 |
K950717 |
SOFAMOR DANEK USA,INC. |
AUGMENT-T POSTERIOR SPINAL SYSTEM |
02/14/1996 |
K984360 |
SOFAMOR DANEK USA,INC. |
COLORADO II SPINAL SYSTEM |
03/30/2000 |
K991031 |
SOFAMOR DANEK USA,INC. |
COLORADO II SPINAL SYSTEM |
05/10/2000 |
K991036 |
SOFAMOR DANEK USA,INC. |
DANEK PLATE AND SCREW SYSTEM |
09/14/1999 |
K991364 |
SOFAMOR DANEK USA,INC. |
MODIFICATION TO TENOR SPINAL SYSTEM-PLATES |
05/19/1999 |
K082453 |
SOLCO BIOMEDICAL CO., LTD. |
4CIS SOLAR AND APOLLON SPINE SYSTEMS |
09/23/2008 |
K050471 |
SOLCO BIOMEDICAL CO., LTD. |
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM |
05/12/2005 |
K102458 |
SOLCO BIOMEDICAL CO., LTD. |
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM |
06/13/2011 |
K060702 |
SOLCO BIOMEDICAL CO., LTD. |
4CIS VANE SPINE SYSTEM |
06/22/2006 |
K101818 |
SOLCO BIOMEDICAL CO., LTD. |
4CIS VANE SPINE SYSTEM |
02/11/2011 |
K043578 |
SOLCO BIOMEDICAL CO., LTD. |
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM |
03/07/2005 |
K060118 |
SPECIALTY SPINE PRODUCTS, LLC |
SSP PEDICLE SCREW SYSTEM |
06/08/2006 |
K013887 |
SPINAL CONCEPTS, INC. |
BACFIX SPINAL FIXATION SYSTEM |
02/12/2002 |
K973687 |
SPINAL CONCEPTS, INC. |
SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM |
03/18/1998 |
K091110 |
SPINAL EDGE, LLC |
SPINAL EDGE TITAN PEDICLE SCREW SYSTEM |
07/24/2009 |
K110633 |
SPINAL SOLUTIONS, LLC |
LANCER PEDICLE SCREW SYSTEM |
12/15/2011 |
K031265 |
SPINE NEXT SA |
SHIRAZ-JAVA SPINAL FIXATION SYSTEM |
10/09/2003 |
K132403 |
SPINE WAVE, INC. |
ANNEXTM ADJACENT LEVEL SYSTEM |
01/10/2014 |
K100605 |
SPINE WAVE, INC. |
MIS SYSTEM |
06/04/2010 |
K100122 |
SPINE WAVE, INC. |
MODIFICATION TO CAPSURE PS SYSTEM |
02/12/2010 |
K081165 |
SPINEART |
ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM |
12/17/2008 |
K101678 |
SPINEART |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
07/28/2010 |
K130267 |
SPINEART |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
05/31/2013 |
K140948 |
SPINEART |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
05/20/2014 |
K151695 |
SPINEART |
Romeo posterior osteosynthesis system |
09/10/2015 |
K102488 |
SPINECRAFT LLC |
APEX SPINE SYSTEM W/ COCR RODS |
12/10/2010 |
K143377 |
SPINEFRONTIER, INC. |
PedFuse Pedicle Screw System |
02/12/2015 |
K123164 |
SPINEFRONTIER, INC. |
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM |
02/15/2013 |
K133153 |
SPINEFRONTIER, INC. |
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM |
05/14/2014 |
K042640 |
SPINEVISION, INC. |
UNI-THREAD SPINAL SYSTEM |
11/23/2004 |
K133575 |
SPINEVISION, S.A. |
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM |
06/30/2014 |
K081331 |
SPINEWORKS, LLC |
FIXXSURE CROSS LINK |
07/23/2008 |
K061813 |
STRYKER SPINE |
MANTIS SPINAL SYSTEM |
09/19/2006 |
K093670 |
STRYKER SPINE |
MODIFICATION TO: OASYS SYSTEM |
03/18/2010 |
K043180 |
STRYKER SPINE |
STRYKER SPINE TRIO PS |
03/02/2005 |
K050461 |
STRYKER SPINE |
XIA 4.5 SPINAL SYSTEM |
07/27/2005 |
K020196 |
SULZER SPINE-TECH |
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM |
02/15/2002 |
K142290 |
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD |
KangLi pedical screw spinal system |
11/24/2014 |
K140053 |
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD |
KANGLI PEDICLE SCREW SPINAL SYSTEM |
06/26/2014 |
K963357 |
SYNTHES (USA) |
MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE |
01/09/1997 |
K963045 |
SYNTHES (USA) |
SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM |
02/13/1997 |
K962608 |
SYNTHES (USA) |
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR |
12/09/1996 |
K991552 |
SYNTHES (USA) |
SYNTHES PEDIATRIC ROD SYSTEM |
06/02/1999 |
K992739 |
SYNTHES SPINE |
CLICK'X |
02/08/2000 |
K980761 |
SYNTHES SPINE |
SYNTHES SPINE PEDIATRIC ROD SYSTEM |
08/04/1998 |
K132101 |
U & I CORPORATION |
ANAX 5.5 SPINAL SYSTEM |
11/25/2013 |
K132218 |
U & I CORPORATION |
PERFIX ILIAC SCREW SYSTEM |
12/17/2013 |
K042928 |
U&I CORP. |
MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM |
02/17/2005 |
K091725 |
U&I CORP. |
PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) |
11/09/2009 |
K031585 |
U&I CORP., AMERICA |
U&I, OPTIMA, SPINAL SYSTEM |
06/27/2003 |
K143417 |
U&I Corporation |
ANAX 5.5 Spinal System |
02/25/2015 |
K162189 |
U&I Corporation |
ANAXÖ 5.5 Spinal System |
08/30/2016 |
K102853 |
ULRICH GMBH & CO. KG |
FLAMENCO SPINAL FIXATION SYSTEM |
01/25/2011 |
K974213 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
AURORA TITANIUM SPINAL ROD SYSTEM |
02/04/1998 |
K974734 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
AURORA TITANIUM SPINAL ROD SYSTEM |
03/10/1998 |
K012273 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SPIRAL RADIUS 90-D SST SYSTEM |
08/15/2001 |
K980862 |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
TITANIUM SPINAL ROD SYSTEM |
05/20/1998 |
K081883 |
US SPINE |
MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM |
09/24/2008 |
K081296 |
US SPINE |
PREFERENCE PEDICLE SCREW SYSTEM |
06/06/2008 |
K140359 |
VALOREM SURGICAL |
MAXIMIS SPINAL FIXATION SYSTEM |
01/07/2015 |
K043152 |
VERTEBRON, INC. |
VERTEBRON PSS PEDICLE SCREW SYSTEM |
02/01/2005 |
K062670 |
VERTIFLEX (TM), INCORPORATED |
VERTIFLEX SPINAL SCREW SYSTEM |
01/12/2007 |
K122994 |
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
INTRAMEDULLARY NAIL SYSTEM |
04/12/2013 |
K961572 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
VERSALOK SCREW ASSEMBLY (PROPOSED NAME) |
09/17/1996 |
K980496 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER |
04/14/1998 |
K120832 |
X-SPINE SYSTEMS, INC |
FORTEX PEDICLE SCREW SYSTEM |
10/23/2012 |
K072282 |
X-SPINE SYSTEMS, INC. |
CAPLESS LI PEDICLE SCREW SYSTEM |
09/14/2007 |
K090224 |
X-SPINE SYSTEMS, INC. |
FORTEX PEDICLE SCREW SYSTEM |
07/30/2009 |
K153404 |
ZAVATION, LLC |
Zavation Spinal System |
04/21/2016 |
K122592 |
ZIMMER SPINE |
INSTINCT JAVA SYSTEM |
01/04/2013 |