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
K100138 ALPHATEC SPINE, INC. ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM 02/17/2010
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
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
K992738 ENCORE ORTHOPEDICS, INC. ISOBAR SPINAL SYSTEM 11/08/1999
K000425 ENCORE ORTHOPEDICS, INC. ISOBAR SPINAL SYSTEM 03/07/2000
K013191 ENCORE ORTHOPEDICS, INC. PASS SPINAL SYSTEM 10/24/2001
K013431 ENCORE ORTHOPEDICS, INC. PASS SPINAL SYSTEM 11/15/2001
K012175 ENCORE ORTHOPEDICS, INC. PASS SPINAL SYSTEM 07/31/2001
K013403 ENDIUS, INC. TRI-FIX SPINAL FIXATION SYSTEM 11/14/2001
K010903 ENDIUS, INC. TRI-FIX SPINAL FIXATION SYSTEM 06/06/2001
K010922 ENDIUS, INC. TRI-FIX SPINAL FIXATION SYSTEM 06/06/2001
K000766 ENDIUS, INC. TRI-FIX SPINAL FIXATION SYSTEM 06/01/2000
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
K100851 K2M, INC. RANGE SPINAL SYSTEM 08/02/2010
K070229 K2M, INC. RANGE SPINAL SYSTEM 05/03/2007
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
K150049 MEDICREA INTERNATIONAL PASS LP Spinal System 02/10/2015
K140738 MEDICREA INTERNATIONAL PASS LP SPINAL SYSTEM 11/04/2014
K070276 MEDICREA TECHNOLOGIES MODIFICATION TO PASSMED SPINAL SYSTEM 09/21/2007
K082069 MEDICREA TECHNOLOGIES PASS 2 SPINAL SYSTEM 10/03/2008
K100297 MEDICREA TECHNOLOGIES PASS LP SPINAL SYSTEM 03/04/2010
K083308 MEDICREA TECHNOLOGIES PASS LP SPINAL SYSTEM 12/10/2008
K083810 MEDICREA TECHNOLOGIES PASS LP SPINAL SYSTEM 07/31/2009
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
K041030 MEDTRONIC SOFAMOR DANEK MODIFICATION TO CD HORIZON SPINAL SYSTEM 06/30/2004
K031888 MEDTRONIC SOFAMOR DANEK MODIFICATION TO CD HORIZON SPINAL SYSTEM 06/27/2003
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
K042453 MEDTRONIC SOFAMOR DANEK, INC. MODIFICATION TO EQUATION FIXATION SYSTEM 10/07/2004
K033495 MEDTRONIC SOFAMOR DANEK, INC. MODIFICATION TO EQUATION FIXATION SYSTEM 12/03/2003
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
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
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
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
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
K093170 SPINEART ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM 11/04/2009
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
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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
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K024096 U&I CORP., AMERICA OPTIMA, SPINAL SYSTEM 03/12/2003
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