FDA 510(k) Applications for Medical Device Product Code "MNI"
(Orthosis, Spinal Pedicle Fixation)
| 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 |
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