FDA 510(k) Applications for Medical Device Product Code "KWP"
(Appliance, Fixation, Spinal Interlaminal)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K052247 | ABBOTT SPINE, INC. | NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX | 09/14/2005 |
| K090060 | ABBOTT SPINE, INC. | NEXLINK OCT SYSTEM, MODEL 7000 SERIES | 06/02/2009 |
| K121136 | ACCEL SPINE | RENOIR POSTERIOR CERVIAL FIXATION SYSTEM | 08/09/2012 |
| K963639 | ACROMED CORP. | ACROMED PEDICLE SCREW | 11/14/1996 |
| K962984 | ACROMED CORP. | ISOLA PEDIATRIC COMPONENTS | 11/27/1996 |
| K954770 | ADVANCED SPINE FIXATION SYSTEMS, INC. | CENTRA-LINE GRAPPLE, VARIFIX SYSTEM | 01/25/1996 |
| K990845 | ADVANCED SPINE FIXATION SYSTEMS, INC. | MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15 | 04/13/1999 |
| K980121 | AESCULAP, INC. | AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS | 06/10/1998 |
| K001080 | AESCULAP, INC. | SPINE SYSTEM EVOLUTION | 06/29/2000 |
| K033090 | ALPHATEC MFG., INC. | ICON POLYAXIAL PEDICLE SCREW SYSTEM | 03/26/2004 |
| K951846 | ALPHATEC MFG., INC. | MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS | 02/14/1996 |
| K103205 | ALPHATEC SPINE, INC. | BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM | 06/02/2011 |
| K052201 | ALPHATEC SPINE, INC. | SOLANAS POSTERIOR STABILIZATION SYSTEM | 11/10/2005 |
| K072081 | ALPHATEC SPINE, INC. | ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM | 10/24/2007 |
| K100685 | ALPHATEC SPINE, INC. | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM | 06/18/2010 |
| K042673 | ALPHATEC/NEXMED | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM | 10/27/2004 |
| K050830 | ALPHATEC/NEXMED | ZODIAC SPINAL FIXATION SYSTEM | 06/22/2005 |
| K061943 | ANATOMICA AB | ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM | 05/25/2007 |
| K971457 | ARCAN ORTHOPAEDIC CORP. | BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED | 07/16/1997 |
| K955927 | ARCAN ORTHOPAEDIC CORP. | BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION) | 03/13/1996 |
| K071377 | BIOMET SPINE | POLARIS BE RODS | 08/06/2007 |
| K113593 | BIOMET SPINE (AKA EBI, LLC) | NEXTGEN ALTIUS OCT SYSTEM | 04/17/2012 |
| K122378 | BIOMET SPINE (AKA EBI, LLC) | NEXTGEN ALTIUS OCT SYSTEM | 09/20/2012 |
| K073420 | BLACKSTONE MEDICAL, INC. | BLACKSTONE ASCENT MULTIAXIAL SCREWS | 02/14/2008 |
| K033980 | BLACKSTONE MEDICAL, INC. | BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION) | 03/03/2004 |
| K073654 | BLACKSTONE MEDICAL, INC. | BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR | 01/24/2008 |
| K080394 | BLACKSTONE MEDICAL, INC. | BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM | 03/13/2008 |
| K030197 | BLACKSTONE MEDICAL, INC. | BLACKSTONE POSTERIOR CERVICAL SYSTEM | 06/12/2003 |
| K023498 | BLACKSTONE MEDICAL, INC. | MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM | 11/13/2002 |
| K030241 | BLACKSTONE MEDICAL, INC. | MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM | 02/21/2003 |
| K133214 | CHOICE SPINE, LP | BLACKBIRD SPINAL SYSTEM | 03/07/2014 |
| K132504 | CORELINK LLC | TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM | 11/25/2013 |
| K072866 | CUSTOM SPINE, INC. | ISSYS LP SPINAL FIXATION SYSTEM | 12/13/2007 |
| K043522 | CUSTOM SPINE, INC. | ISSYS PEDICLE SCREW SYSTEM | 01/14/2005 |
| K022623 | DEPUY ACROMED | 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM) | 08/27/2002 |
| K001372 | DEPUY ACROMED | E-Z LINK CROSS CONNECTOR | 07/27/2000 |
| K001470 | DEPUY ACROMED | E-Z LINK CROSS CONNECTOR | 08/04/2000 |
| K003822 | DEPUY ACROMED | ISOLA CLOSED DUAL ROD CONNECTOR | 01/08/2001 |
| K013441 | DEPUY ACROMED | ISOLA POLYAXIAL WASHER | 11/16/2001 |
| K002607 | DEPUY ACROMED | MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS | 09/12/2000 |
| K001105 | DEPUY ACROMED | MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS | 04/24/2000 |
| K023804 | DEPUY ACROMED | MOSS MIAMI SPINAL SYSTEM PIN NUT | 01/23/2003 |
| K002733 | DEPUY ACROMED | SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM | 12/15/2000 |
| K010681 | DEPUY ACROMED | SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM | 07/18/2001 |
| K982011 | DEPUY ORTHOPAEDICS, INC. | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM | 08/06/1998 |
| K070300 | DEPUY SPINE, INC. | EXPEDIUM SFX CROSS CONNECTOR SYSTEM | 04/10/2007 |
| K041119 | DEPUY SPINE, INC. | EXPEDIUM SPINE SYSTEM | 07/19/2004 |
| K052131 | DEPUY SPINE, INC. | EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS | 09/28/2005 |
| K110353 | DEPUY SPINE, INC. | MOUNTAINEER OCT SPINAL SYSTEM | 04/07/2011 |
| K042508 | DEPUY SPINE, INC. | SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM | 10/07/2004 |
| K983583 | DEPUY, INC. | DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS | 12/03/1998 |
| K965145 | DEPUY, INC. | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM | 03/13/1997 |
| K982320 | DEPUY, INC. | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM | 09/14/1998 |
| K982511 | DEPUY, INC. | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS | 09/14/1998 |
| K974573 | DEPUY, INC. | DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM | 02/18/1998 |
| K964024 | DEPUY, INC. | DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM | 03/26/1997 |
| K962628 | DEPUY, INC. | MOSS MIAMI SPINAL SYSTEM | 03/18/1997 |
| K955348 | DEPUY, INC. | TITANIUM MOSS MIAMI SPINAL SYSTEM | 02/16/1996 |
| K113324 | DIO MEDICAL CO., LTD. | REXIOUS HOOK FIXATION SYSTEMS | 03/28/2012 |
| K012516 | EBI, L.P. | EBI SPINELINK - II SPINAL FIXATION SYSTEM | 11/27/2001 |
| K140734 | EBI, LLC | NEXTGEN ALTIUS OCT SYSTEM | 12/15/2014 |
| K990303 | ELECTRO-BIOLOGY, INC. | EBI OMEGA 21 SYSTEM | 04/29/1999 |
| K982908 | ELECTRO-BIOLOGY, INC. | MODIFICATION TO EBI SPINELINK SYSTEM | 08/28/1998 |
| K002959 | ENCORE ORTHOPEDICS, INC. | MODIFICATION TO ISOBAR SPINAL SYSTEM | 10/16/2000 |
| K020236 | ENCORE ORTHOPEDICS, INC. | MODIFICATION TO PASS SPINAL SYSTEM | 02/14/2002 |
| K013442 | ENCORE ORTHOPEDICS, INC. | PASS SPINAL SYSTEM | 01/15/2002 |
| K060683 | ENDIUS, INC. | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM | 04/18/2006 |
| K014090 | ENDIUS, INC. | ENDIUS SPINAL FIXATION SYSTEM | 03/11/2002 |
| K041808 | ENDIUS, INC. | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM | 10/01/2004 |
| K011830 | ENDIUS, INC. | TRI-FIX SPINAL FIXATION SYSTEM | 07/23/2001 |
| K140645 | EXACTECH SARASOTA | GIBRALT ROD-TO-ROD CROSS CONNECTORS | 04/11/2014 |
| K121877 | EXACTECH, INC. | GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES | 02/12/2013 |
| K090565 | GLOBUS MEDICAL INC. | ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM | 06/30/2009 |
| K110963 | GLOBUS MEDICAL INC. | ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM | 05/05/2011 |
| K052069 | GLOBUS MEDICAL INC. | PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES | 08/17/2005 |
| K123783 | GLOBUS MEDICAL, INC. | ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS | 03/14/2013 |
| K081906 | GLOBUS MEDICAL, INC. | PROTEX CT CERVICOTHORACIC SPINAL SYSTEM | 11/14/2008 |
| K050391 | GLOBUS MEDICAL, INC. | PROTEX CT CERVICOTHORACIC SPINAL SYSTEM | 07/21/2005 |
| K102195 | GLOBUS MEDICAL, INC. | SP-FIX SPINOUS PROCESS FIXATION PLATE | 01/19/2011 |
| K070966 | GOLD STANDARD ORTHOPAEDICS, LLC | GSO GS1 SPINAL SYSTEM | 07/20/2007 |
| K091359 | GOLD STANDARD ORTHOPAEDICS, LLC | GSO PCT SPINAL SYSTEM | 09/02/2009 |
| K982494 | HOWMEDICA CORP. | BWM SPINE SYSTEM | 09/08/1998 |
| K031090 | HOWMEDICA OSTEONICS CORP. | MODIFICATION TO XIA STAINLESS STEEL SYSTEM | 04/24/2003 |
| K990922 | HOWMEDICA OSTEONICS CORP. | OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR | 06/02/1999 |
| K013823 | HOWMEDICA OSTEONICS CORP. | XIA SPINAL SYSTEM | 12/19/2001 |
| K031893 | HOWMEDICA OSTEONICS CORP. | XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM | 07/17/2003 |
| K002505 | HOWMEDICA OSTEONICS CORP. | XIA SPINE SYSTEM | 10/05/2000 |
| K001653 | HOWMEDICA OSTEONICS CORP. | XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY | 08/18/2000 |
| K012870 | HOWMEDICA OSTEONICS CORP. | XIA STAINLESS STEEL SYSTEM | 09/24/2001 |
| K042143 | INNOVASIS, INC. | EXCELLA-M SPINAL SYSTEM | 10/07/2004 |
| K132900 | INTELLIGENT IMPLANT SYSTEMS, LLC | MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM | 10/25/2013 |
| K033961 | INTERPORE CROSS INTL. | ALTIUS OCT SYSTEM | 04/14/2004 |
| K022048 | INTERPORE CROSS INTL. | INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM | 12/04/2002 |
| K043229 | INTERPORE CROSS INTL. | MODIFICATION TO ALTIUS OCT SYSTEM | 12/21/2004 |
| K010515 | INTERPORE CROSS INTL. | MODIFICATION TO SYNERGY SPINAL SYSTEM | 03/22/2001 |
| K041449 | INTERPORE CROSS INTL. | SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT | 07/01/2004 |
| K012871 | INTERPORE CROSS INTL. | SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177 | 09/13/2001 |
| K031772 | INTERPORE CROSS INTL. | TI FENESTRATED PLATE | 09/05/2003 |
| K955864 | J.B.S., S.A. | J.B. S. C1-C2 CLAMP | 03/15/1996 |
| K142460 | JOHNSON AND JOHNSON | EXPEDIUM Spine System/Synapse System | 10/01/2014 |
| K142558 | K2M | Caspian OCT/MESA Mini/DENALI Mini Spinal System | 12/22/2014 |
| K121808 | K2M, INC. | CASIAN, 3.5/4.5 CONNECTORS | 07/20/2012 |
| K113654 | K2M, INC. | CASPIAN | 01/12/2012 |
| K133288 | K2M, INC. | CASPIAN OCT SPINAL SYSTEM | 07/01/2014 |
| K101084 | K2M, INC. | CASPIAN SPINAL SYSTEM | 10/04/2010 |
| K103232 | K2M, INC. | CASPIAN SPINAL SYSTEM | 01/13/2011 |
| K141284 | K2M, INC. | CASPIAN SPINAL SYSTEM | 07/23/2014 |
| K081107 | K2M, INC. | CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS | 10/10/2008 |
| K082769 | K2M, INC. | MESA AND RANGE SPINAL SYSTEMS | 12/11/2008 |
| K093534 | K2M, INC. | MODIFICATION TO CASPIAN SPINAL SYSTEM | 12/16/2009 |
| K052404 | K2M, LLC | DENALI DEFORMITY SYSTEM | 05/23/2006 |
| K042635 | K2M, LLC | DENALI SPINE SYSTEM | 01/10/2005 |
| K143278 | L&K BIOMED Co., Ltd. | LnK Posterior Cervical Fixation System | 07/29/2015 |
| K092656 | LANX, INC. | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM | 11/24/2009 |
| K100191 | LANX, INC. | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | 04/15/2010 |
| K131156 | LANX, INC. | LANX SPINAL FIXATION SYSTEM | 05/24/2013 |
| K103091 | LANX, INC. | LANX SPINAL FIXATION SYSTEM | 04/15/2011 |
| K100888 | LANX, INC. | MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM | 11/15/2010 |
| K090252 | LANX, INC. | MODIFICATION TO: LANX SPINAL FIXATION SYSTEM | 03/04/2009 |
| K071633 | LANX, LLC | LANX DEFORMITY SYSTEM | 08/15/2007 |
| K070341 | LDR SPINE USA | LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM | 08/08/2007 |
| K090343 | LIFE SPINE | SENTINEL SPINAL SYSTEM | 08/11/2009 |
| K120998 | LIFE SPINE | SOLSTICE CROSS CONNECTOR | 10/01/2012 |
| K150229 | LIFE SPINE, INC | SOLSTICE OCT System | 04/07/2015 |
| K142253 | LIFE SPINE, INC | SOLSTICE OCT System | 04/23/2015 |
| K143249 | LIFE SPINE, INC | SOLSTICE OCT System | 04/07/2015 |
| K121115 | MEDACTA INTERNATIONAL | M.U.S.T PEDICLE SCREW SYSTEM | 07/18/2012 |
| K032094 | MEDICREA | PASSMED SPINAL SYSTEM | 11/14/2003 |
| K121979 | MEDICREA INTERNATIONAL | PASS OCT SPINAL SYSTEM | 03/21/2013 |
| K062181 | MEDICREA TECHNOLOGIES | C-JAWS CERVICAL COMPRESSIVE MINI FRAME | 01/16/2007 |
| K132332 | MEDOS INTERNATIONAL SARL | MOUNTAINEER OCT SPINAL SYSTEM | 08/22/2013 |
| K091365 | MEDTRONIC SOAFAMOR DANEK | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM | 08/06/2009 |
| K060081 | MEDTRONIC SOFAMOR DANEK | BASIS SPINAL SYSTEM | 02/13/2006 |
| K014296 | MEDTRONIC SOFAMOR DANEK | CD HORIZON SPINAL SYSTEM | 12/10/2002 |
| K041862 | MEDTRONIC SOFAMOR DANEK | CD HORIZON SPINAL SYSTEM | 09/15/2004 |
| K020155 | MEDTRONIC SOFAMOR DANEK | DYNA-LOK CLASSIC SPINAL SYSTEM | 02/05/2002 |
| K043020 | MEDTRONIC SOFAMOR DANEK | GLAXY 3.2 SPINAL SYSTEM | 01/07/2005 |
| K023797 | MEDTRONIC SOFAMOR DANEK | LAURAIN DEWALD ANTERIOR FIXATION SYSTEM | 12/13/2002 |
| K020709 | MEDTRONIC SOFAMOR DANEK | MODIFICATION TO CD HORIZON SPINAL SYSTEM | 05/09/2002 |
| K021061 | MEDTRONIC SOFAMOR DANEK | MODIFICATION TO CD HORIZON SPINAL SYSTEM | 07/25/2002 |
| K043053 | MEDTRONIC SOFAMOR DANEK | MODIFICATION TO CD HORIZON SPINAL SYSTEM | 04/11/2005 |
| K061579 | MEDTRONIC SOFAMOR DANEK | MODIFICATION TO CD HORIZON SPINAL SYSTEM | 08/11/2006 |
| K023415 | MEDTRONIC SOFAMOR DANEK | MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM | 12/13/2002 |
| K042524 | MEDTRONIC SOFAMOR DANEK | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | 10/08/2004 |
| K052180 | MEDTRONIC SOFAMOR DANEK | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | 08/23/2005 |
| K070742 | MEDTRONIC SOFAMOR DANEK | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | 09/14/2007 |
| K071942 | MEDTRONIC SOFAMOR DANEK | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | 12/11/2007 |
| K080805 | MEDTRONIC SOFAMOR DANEK | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | 04/18/2008 |
| K052376 | MEDTRONIC SOFAMOR DANEK | MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM | 09/23/2005 |
| K052734 | MEDTRONIC SOFAMOR DANEK | MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM | 10/21/2005 |
| K030816 | MEDTRONIC SOFAMOR DANEK | MSD CABLE REDUCTION SYSTEM | 06/06/2003 |
| K042498 | MEDTRONIC SOFAMOR DANEK | VERTEX RECONSTRUCTION SYSTEM | 10/07/2004 |
| K042789 | MEDTRONIC SOFAMOR DANEK | VERTEX RECONSTRUCTION SYSTEM | 12/21/2004 |
| K052402 | MEDTRONIC SOFAMOR DANEK | VERTEX RECONSTRUCTION SYSTEM | 09/23/2005 |
| K081297 | MEDTRONIC SOFAMOR DANEK | VERTEX RECONSTRUCTION SYSTEM | 06/11/2008 |
| K083071 | MEDTRONIC SOFAMOR DANEK | VERTEX RECONSTRUCTION SYSTEM | 11/14/2008 |
| K090714 | MEDTRONIC SOFAMOR DANEK | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM | 04/17/2009 |
| K010632 | MEDTRONIC SOFAMOR DANEK USA, INC. | BUTTERFLY PLATE FUNCTION SYSTEM | 05/31/2001 |
| K050079 | MEDTRONIC SOFAMOR DANEK USA, INC. | CD HORIZON SPINAL SYSTEM | 02/10/2005 |
| K050809 | MEDTRONIC SOFAMOR DANEK USA, INC. | CD HORIZON SPINAL SYSTEM | 06/14/2005 |
| K002103 | MEDTRONIC SOFAMOR DANEK USA, INC. | SIMPLICITY SPINAL SYSTEM | 11/02/2000 |
| K021170 | MEDTRONIC SOFAMOR DANEK USA, INC. | TSRH SPINAL SYSTEM | 07/09/2002 |
| K123568 | MEDTRONIC SOFAMOR DANEK USA, INC. | VERTEX RECONSTRUCTION SYSTEM | 12/18/2012 |
| K110522 | MEDTRONIC SOFAMOR DANEK USA, INC. | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM | 04/01/2011 |
| K123656 | MEDTRONIC SOFAMOR DANEK USA, INC. | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM | 02/25/2013 |
| K123906 | MEDTRONIC SOFAMOR DANEK USA, INC. | VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM | 04/01/2013 |
| K082728 | MEDTRONIC SOFAMOR DANEK USA, INC. | VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM | 01/16/2009 |
| K050484 | MEDTRONIC SOFAMOR DANEK, INC. | BASIS SPINAL SYSTEM | 05/04/2005 |
| K014267 | MEDTRONIC SOFAMOR DANEK, INC. | BUTTERFLY PLATE FIXATION SYSTEM | 01/25/2002 |
| K011508 | MEDTRONIC SOFAMOR DANEK, INC. | CD HORIZON SPINAL SYSTEM | 06/12/2001 |
| K102886 | MEDTRONIC SOFAMOR DANEK, INC. | CD HORIZON SPINAL SYSTEM | 01/26/2011 |
| K010181 | MEDTRONIC SOFAMOR DANEK, INC. | CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION | 06/12/2001 |
| K001532 | MEDTRONIC SOFAMOR DANEK, INC. | DYNA-LOK CLASSIC SPINAL SYSTEM | 06/16/2000 |
| K061591 | MEDTRONIC SOFAMOR DANEK, INC. | MODIFICATION TO CD HORIZON SPINAL SYSTEM | 09/08/2006 |
| K030875 | MEDTRONIC SOFAMOR DANEK, INC. | MODIFICATION TO COLORADO 2 SPINAL SYSTEM | 06/24/2003 |
| K022191 | MEDTRONIC SOFAMOR DANEK, INC. | MODIFICATION TO TENOR SPINAL SYSTEM | 08/28/2002 |
| K041282 | MEDTRONIC SOFAMOR DANEK, INC. | MODIFICATION TO TSRH SPINAL SYSTEM | 06/10/2004 |
| K022015 | MEDTRONIC SOFAMOR DANEK, INC. | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | 07/18/2002 |
| K023555 | MEDTRONIC SOFAMOR DANEK, INC. | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | 11/22/2002 |
| K042402 | MEDTRONIC SOFAMOR DANEK, INC. | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | 10/01/2004 |
| K020426 | MEDTRONIC SOFAMOR DANEK, INC. | MSD WIRE SYSTEM | 02/26/2002 |
| K062447 | MEDTRONIC SOFAMOR DANEK, INC. | TRAVERSE OCT SPINAL FIXATION SYSTEM | 10/15/2007 |
| K031533 | MEDTRONIC SOFAMOR DANEK, INC. | VANTAGE ANTERIOR FIXATION SYSTEM | 06/13/2003 |
| K121191 | MEDTRONIC SOFAMOR DANEK, INC. | VERTEX RCCONSTRUCTION SYSTEM | 06/29/2012 |
| K003780 | MEDTRONIC SOFAMOR DANEK, INC. | VERTEX RECONSTRUCTION SYSTEM | 09/28/2001 |
| K022070 | MEDTRONIC SOFAMOR DANEK, INC. | XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM | 07/22/2002 |
| K002059 | MICRON PRECISION ENGINEERING, INC. | AMT SPINAL SYSTEM | 11/13/2000 |
| K093319 | NUVASIVE, INC. | NUVASIVE VUEPOINT OCT SYSTEM | 06/23/2010 |
| K073278 | NUVASIVE, INC. | SPINOUS PROCESS PLATE SYSTEM | 03/28/2008 |
| K983282 | OHIO MEDICAL INSTRUMENT CO., INC. | OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 | 11/19/1998 |
| K132122 | OMNI SURGICAL LLC DBA SPINE360 | KESTREL POSTERIOR CERVICAL SPINE SYSTEM | 01/22/2014 |
| K990986 | ORTHO DEVELOPMENT CORP. | CONTOUR SPINAL SYSTEM | 10/14/1999 |
| K111183 | ORTHOFIX INC. | ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS) | 05/24/2011 |
| K131833 | ORTHOFIX, INC. | CENTURION POCT SYSTEM | 01/30/2014 |
| K983353 | ORTHOTEC, INC. | SCS SPINAL SYSTEM | 12/18/1998 |
| K023884 | ORTHOTEC, L.L.C. | MODIFICATION ORIA SPINAL SYSTEM | 08/20/2003 |
| K021679 | ORTHOTEC, L.L.C. | ORIA SPINAL CLIP SYSTEM | 11/19/2002 |
| K030252 | ORTHOTEC, L.L.C. | ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07) | 02/21/2003 |
| K031471 | ORTHOTEC, L.L.C. | ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01 | 10/10/2003 |
| K030253 | ORTHOTEC, L.L.C. | ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 | 02/21/2003 |
| K031452 | ORTHOTEC, L.L.C. | ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 | 06/18/2003 |
| K003823 | ORTHOTEC, L.L.C. | SCS DT-02 TRANSVERSE CONNECTOR | 07/11/2001 |
| K001535 | ORTHOTEC, L.L.C. | ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION | 03/20/2001 |
| K021919 | ORTHOTEC,LLC | SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO | 07/03/2002 |
| K100354 | OSTEOMED L.P. | PRIMAL OK INTERSPINOUS FUSION SYSTEM | 08/17/2010 |
| K962314 | OSTEONICS CORP. | HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM | 12/09/1996 |
| K981452 | OSTEONICS CORP. | OSTEONICS LONG ARM CONTAINMENT RING | 05/20/1998 |
| K984375 | OSTEONICS CORP. | OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY | 04/30/1999 |
| K955173 | OSTEOTECH, INC. | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | 02/09/1996 |
| K971289 | OSTEOTECH, INC. | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | 06/18/1997 |
| K973868 | OSTEOTECH, INC. | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | 01/08/1998 |
| K991586 | OSTEOTECH, INC. | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) | 07/23/1999 |
| K992885 | OSTEOTECH, INC. | VERSALOK LOW BACK FIXATION SYSTEM | 11/19/1999 |
| K112595 | PARADIGM SPINE, LLC | COFLEX-F | 02/13/2012 |
| K093438 | PARADIGM SPINE, LLC | PARADIGM INTERSPINOUS FUSION PLATE | 10/06/2010 |
| K092295 | PIONEER SURGICAL TECHNOLOGY | PIONEER POSTERIOR CERVICO-THORACIC SYSTEM | 02/19/2010 |
| K101525 | PIONEER SURGICAL TECHNOLOGY | PIONEER SPINOUS PROCESS FUSION PLATE | 10/22/2010 |
| K121725 | PIONEER SURGICAL TECHNOLOGY, INC | PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM | 11/07/2012 |
| K110367 | PIONEER SURGICAL TECHNOLOGY, INC | PIONEER SPINAL PROCESS FUSION PLATE | 03/23/2011 |
| K112757 | PIONEER SURGICAL TECHNOLOGY, INC. | PIONEER POSTERIOR CERVICO THORACIC SYSTEM | 03/12/2012 |
| K150254 | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) | Streamline OCT Occipito-Cervico-Thoracic System | 04/28/2015 |
| K133374 | PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I | STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM | 03/19/2014 |
| K150851 | PRECISION SPINE, INC. | Sure Lok Mini Posterior Cervical/Upper Thoracic System | 06/04/2015 |
| K101112 | RELIANCE MEDICAL SYSTEMS | RELIANCE SPINAL SCREW SYSTEM | 11/04/2010 |
| K122292 | Reliance Medical Systems, LLC | RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM | 10/24/2012 |
| K142867 | Reliance Medical Systems, LLC | Reliance Posterior Cervical-Thoracic System | 04/29/2015 |
| K013447 | SCIEN'TX USA INC. | ISOBAR SPINAL SYSTEM | 01/15/2002 |
| K051942 | SEASPINE, INC. | MALIBU SPINAL SYSTEM | 07/27/2005 |
| K072729 | SEASPINE, INC. | SIERRA | 04/17/2008 |
| K080526 | SEASPINE, INC. | SIERRA SYSTEM | 04/16/2008 |
| K060513 | SINTEA BIOTECH, INC. | SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X | 03/10/2006 |
| K043355 | SINTEA BIOTECH, INC. | SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X | 12/17/2004 |
| K965224 | SMITH & NEPHEW RICHARDS, INC. | EMPOWER ANTERIOR DIRECT SCREWS | 05/08/1997 |
| K960444 | SMITH & NEPHEW RICHARDS, INC. | FINN ROD TO ROD CONNECTOR | 01/24/1997 |
| K954696 | SMITH & NEPHEW RICHARDS, INC. | ROGOZINSKI THORACOLUMBAR SPINAL ROD | 03/11/1996 |
| K964275 | SOFAMOR DANEK USA,INC. | ALPHA POSTERIOR SPINAL SYSTEM | 01/14/1997 |
| K961633 | SOFAMOR DANEK USA,INC. | CD HORIZON SPINAL SYSTEM | 12/05/1996 |
| K981676 | SOFAMOR DANEK USA,INC. | CD HORIZON SPINAL SYSTEM | 01/28/1999 |
| K951164 | SOFAMOR DANEK USA,INC. | CD LIBERTY POSTERIOR SPINCAL SYSTEM | 02/09/1996 |
| K964159 | SOFAMOR DANEK USA,INC. | CD SPINAL SYSTEM | 10/16/1997 |
| K955365 | SOFAMOR DANEK USA,INC. | COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM | 03/27/1996 |
| K955807 | SOFAMOR DANEK USA,INC. | COTREL-DUBOUSSET (CD) SPINAL | 10/01/1996 |
| K991198 | SOFAMOR DANEK USA,INC. | DYNA-LOK PLUS SPINAL SYSTEM | 08/27/1999 |
| K983706 | SOFAMOR DANEK USA,INC. | MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM | 11/12/1998 |
| K982490 | SOFAMOR DANEK USA,INC. | TENOR SPINAL SYSTEM | 10/05/1998 |
| K962708 | SOFAMOR DANEK USA,INC. | TITANIUM CD HORIZON SPINAL SYSTEM | 02/06/1997 |
| K954645 | SOFAMOR DANEK USA,INC. | TITANIUM GDLH POSTERIOR SPINAL SYSTEM | 01/16/1996 |
| K964254 | SOFAMOR DANEK USA,INC. | TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM | 04/21/1997 |
| K123093 | SOUTHERN SPINE, LLC | STABILINK MIS SPINAL FIXATION SYSTEM | 12/20/2012 |
| K964404 | SPINAL CONCEPTS, INC. | BACFIX SPINAL FIXATION SYSTEM | 03/26/1997 |
| K021009 | SPINAL CONCEPTS, INC. | OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM | 06/18/2002 |
| K003351 | SPINAL CONCEPTS, INC. | PARSFIX CABLE-SCREW SYSTEM | 01/24/2001 |
| K002082 | SPINAL CONCEPTS, INC. | SPEEDLINK TRANSVERSE CONNECTOR | 10/06/2000 |
| K040096 | SPINAL CONCEPTS, INC. | SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM | 07/01/2004 |
| K131427 | SPINAL ELEMENTS, INC. | LOTUS | 10/24/2013 |
| K002069 | SPINAL INNOVATIONS, LLC. | ASCEND SPINAL FIXATION SYSTEM | 10/05/2000 |
| K013196 | SPINAL INNOVATIONS, LLC. | ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM | 01/30/2002 |
| K112025 | SPINAL USA | SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM | 09/15/2011 |
| K021507 | SPINE VISION, INC | PLUS PIVOT LINK UNIVERSAL SYSTEM | 08/01/2002 |
| K980288 | SPINE-TECH, INC. | SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM | 07/29/1998 |
| K062513 | SPINECRAFT, INC. | APEX SPINE SYSTEM | 12/22/2006 |
| K092825 | SPINECRAFT, INC. | APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER | 03/16/2010 |
| K102020 | SPINEFRONTIER, INC. | VEGA SPAN SPINOUS PROCESS PLATE SYSTEM | 09/01/2010 |
| K123232 | SPINEOLOGY, INC. | SPINEOLOGY SPINOUS PROCESS PLATE | 02/07/2013 |
| K013312 | SPINEVISION, INC. | P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM) | 02/13/2002 |
| K142741 | STRYKER CORPORATION | OASYS System | 01/15/2015 |
| K150753 | STRYKER CORPORATION | OASYS System | 06/09/2015 |
| K072568 | STRYKER SPINE | MODIFICATION TO OASYS SYSTEM | 10/05/2007 |
| K043473 | STRYKER SPINE | MODIFICATION TO XIA SPINAL SYSTEM | 01/12/2005 |
| K052181 | STRYKER SPINE | MODIFICATION TO XIA SPINAL SYSTEM | 09/08/2005 |
| K051973 | STRYKER SPINE | MODIFICATION TO: XIA STAINLESS STEEL SYSTEM | 08/18/2005 |
| K101183 | STRYKER SPINE | MODIFICATION TO: OASYS SYSTEM | 11/09/2010 |
| K111719 | STRYKER SPINE | OASYS SPINAL SYSTEM | 01/19/2012 |
| K050189 | STRYKER SPINE | TECHTONIX SYSTEM | 02/16/2005 |
| K022374 | SULZER SPINE-TECH | CADENCE SPINAL FIXATION SYSTEM | 09/24/2002 |
| K012173 | SULZER SPINE-TECH | DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM | 09/28/2001 |
| K993067 | SULZER SPINE-TECH | SILHOUETTE SPINAL FIXATION SYSTEM | 11/16/1999 |
| K965221 | SURGICRAFT LTD. | RANSFORD CERVICAL FIXATION SYSTEM | 08/07/1997 |
| K991662 | SURGICRAFT LTD. | TITANIUM HARTSHILL SYSTEM | 11/08/1999 |
| K031175 | SYNTHES (USA) | CLICK'X MONOAXIAL SCREWS AND HOOKS | 11/14/2003 |
| K091689 | SYNTHES (USA) | SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM | 07/10/2009 |
| K990965 | SYNTHES (USA) | SYNTHES CERVIFIX SYSTEM | 07/01/1999 |
| K994187 | SYNTHES (USA) | SYNTHES CERVIFIX SYSTEM | 12/21/1999 |
| K011969 | SYNTHES (USA) | SYNTHES CERVIFIX SYSTEM | 07/19/2001 |
| K023675 | SYNTHES (USA) | SYNTHES CERVIFIX/ AXON | 11/26/2002 |
| K052123 | SYNTHES (USA) | SYNTHES PANGEA SYSTEM | 09/23/2005 |
| K983530 | SYNTHES (USA) | SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM | 12/16/1998 |
| K984377 | SYNTHES (USA) | SYNTHES SPINE CERVIFIX SYSTEM | 01/21/1999 |
| K982322 | SYNTHES (USA) | SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM | 11/25/1998 |
| K980358 | SYNTHES (USA) | SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM | 04/16/1998 |
| K002517 | SYNTHES (USA) | USS VAS | 09/12/2000 |
| K991089 | SYNTHES SPINE | SYNTHES CERVIFIX SYSTEM | 08/27/1999 |
| K980928 | SYNTHES SPINE | SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM | 05/11/1998 |
| K090549 | SYNTHES SPINE | SYNTHES SYNAPSE TRANSCONNECTOR | 05/21/2009 |
| K053418 | SYNTHES SPINE CO.LP | SYNTHES OC FUSION SYSTEM | 09/06/2006 |
| K133698 | SYNTHES USA PRODUCTS LLC | SYNAPSE SYSTEM | 01/16/2014 |
| K141897 | SYNTHES USA PRODUCTS, LLC | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM | 09/25/2014 |
| K003911 | TERRAY CORP. | TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE) | 03/13/2001 |
| K080790 | THEKEN SPINE LLC | MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM | 04/29/2008 |
| K070638 | THEKEN SPINE LLC | THEKEN ATOLL CERVICO-THORACIC SYSTEM | 05/30/2007 |
| K041592 | THEKEN SURGICAL | CORAL SPINAL SYSTEM | 09/16/2004 |
| K031595 | U&I CORP., AMERICA | U & I AMERICA SPINAL HOOK SYSTEM | 06/24/2003 |
| K113346 | ULRICH GMBH & CO. KG | NEON SYSTEM | 02/28/2012 |
| K021825 | UNITED STATES SURGICAL | MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM | 07/01/2002 |
| K983904 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC | ROGOZINSKI SPINAL ROD SYSTEM | 12/22/1998 |
| K020134 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC | SPIRAL RADIUS 90-D RODDING SYSTEM | 04/15/2002 |
| K983197 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC | SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM) | 10/26/1998 |
| K062785 | US SPINE | LTD POLYAXIAL FIXATION SYSTEM | 12/26/2006 |
| K051716 | VERTEBRON, INC. | VERTEBRON PSS PEDICLE SCREW SYSTEM | 09/07/2005 |
| K122509 | VERTIFLEX, INC. | VERTIFLEX SPINOUS PROCESS FIXATION PLATE | 12/17/2012 |
| K990708 | WRIGHT MEDICAL TECHNOLOGY, INC. | TITANIUM VERSALOK | 03/30/1999 |
| K112592 | X-SPINE SYSTEMS, INC | AXLE PEEK INTERSPINOUS FUSION SYSTEM | 12/05/2011 |
| K133094 | X-SPINE SYSTEMS, INC | CERTEX OCT SPINAL IMPLANT SYSTEM | 12/11/2013 |
| K101471 | X-SPINE SYSTEMS, INC. | AXLE INTERSPINOUS FUSION SYSTEM | 11/24/2010 |
| K041925 | ZIMMER SPINE, INC. | ST360 SPINAL FIXATION SYSTEM | 09/24/2004 |
| K133556 | ZIMMER SPINE, INC. | VIRAGE OCT SPINAL FIXATION SYSTEM | 06/02/2014 |
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