FDA 510(k) Applications for Medical Device Product Code "MNH"
(Orthosis, Spondyloisthesis Spinal Fixation)

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
K951116 ACROMED CORP. ACROMED PEDICLE SCREW 08/11/1995
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
K944756 ACROMED CORP. ISOLA OPEN AND CLOSED SCREWS 05/30/1995
K944737 ACROMED CORP. ISOLA SPINE SYSTEM 06/22/1995
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
K944736 ACROMED CORP. VSP (VARIABLE SCREW PLACEMENT) 05/05/1995
K951657 ACROMED CORP. VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S) 08/21/1995
K103573 ADVANCED MEDICAL TECHNOLOGIES ARTS2 SPINAL FIXATION SYSTEM 12/28/2011
K951308 ADVANCED SPINE FIXATION SYSTEMS, INC. 5.8MM DIAMETER ANCHOR SCREW 07/26/1995
K953779 ADVANCED SPINE FIXATION SYSTEMS, INC. SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM 11/07/1995
K953778 ADVANCED SPINE FIXATION SYSTEMS, INC. SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM 11/06/1995
K942387 ADVANCED SPINE FIXATION SYSTEMS, INC. SELBY INSTRUMENTATION 02/14/1995
K943775 ADVANCED SPINE FIXATION SYSTEMS, INC. SELBY INSTRUMENTATION 04/26/1995
K945064 ADVANCED SPINE FIXATION SYSTEMS, INC. SELBY INSTRUMENTATION 04/26/1995
K953369 ADVANCED SPINE FIXATION SYSTEMS, INC. STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW 09/08/1995
K951172 ADVANCED SPINE FIXATION SYSTEMS, INC. TITANIUM LOW PROFILE CROSS BAR 07/25/1995
K951266 ADVANCED SPINE TECHNOLOGY, INC. AMSET R-F SYSTEM 11/21/1995
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
K953416 ARCAN ORTHOPAEDIC CORP. BRYAN POSTERIOR SPINAL FIXATOR (BPSF) 10/03/1995
K090424 BK MEDITECH CO., LTD. DVX SPINE SYSTEM 05/14/2009
K080876 BK MEDITECH CO., LTD. DVX SPINE SYSTEM 06/04/2008
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
K940631 CROSS MEDICAL PRODUCTS, INC. CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM 07/13/1995
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
K936307 DANEK GROUP, INC. DYNA-LOK ANTERIOR PLATING SYSTEM 08/14/1995
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
K950697 DEPUY MOTECH DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION 06/22/1995
K950695 DEPUY MOTECH DEPUY MOTECH MOSS SPINAL SYSTEM - PEDICLE FIXATION 07/21/1995
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
K010535 ENDIUS, INC. TRIFIX SPINAL FIXATION SYSTEM 03/19/2001
K001627 ENDIUS, INC. TRIFIX SPINAL FIXATION SYSTEM 06/03/2000
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
K952298 J.B.S., S.A. SPINAL PEDICLE SCREW, FIXATION, APPLIANCE 12/13/1995
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
K010249 MEDTRONIC SOFAMOR DANEK, INC. CD HORIZON SPINAL SYSTEM 02/23/2001
K000641 MEDTRONIC SOFAMOR DANEK, INC. CD HORIZON SPINAL SYSTEM 12/22/2000
K001255 MEDTRONIC SOFAMOR DANEK, INC. CD HORIZON SPINAL SYSTEM 07/11/2000
K020247 MEDTRONIC SOFAMOR DANEK, INC. COLORADO 2 SPINAL SYSTEM 07/22/2002
K013962 MEDTRONIC SOFAMOR DANEK, INC. EQUATION FIXATION SYSTEM 06/20/2002
K040072 MEDTRONIC SOFAMOR DANEK, INC. MODIFICATION TO CD HORIZON SPINAL SYSTEM 02/12/2004
K002399 MEDTRONIC SOFAMOR DANEK, INC. MODIFICATION TO CD HORIZON SPINAL SYSTEM 09/27/2000
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
K951725 OSTEONICS CORP. OSTEONICS SPINAL SYSTEM 09/08/1995
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
K950865 SMITH & NEPHEW RICHARDS, INC. ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLT 09/01/1995
K930298 SMITH & NEPHEW RICHARDS, INC. ROGOZINSKI SPINAL ROD SYSTEM SCREW 06/14/1995
K930353 SMITH & NEPHEW, INC. SIMMONS PLATING SYSTEM BOLT AND SCREW 06/20/1995
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
K932029 SOFAMOR DANEK MFG., INC. TSRH SPINAL SCREWS 01/20/1995
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
K950596 SOFAMOR DANEK USA,INC. GDLH POSTERIOR SPINAL SYSTEM 08/28/1995
K991364 SOFAMOR DANEK USA,INC. MODIFICATION TO TENOR SPINAL SYSTEM-PLATES 05/19/1999
K950955 SOFAMOR DANEK USA,INC. PARAGON POSTERIOR SPINAL SYSTEM 08/25/1995
K953635 SOFAMOR DANEK USA,INC. TITANIUM DYNA-LOK SPINAL SYSTEM 10/30/1995
K946348 SOFAMOR DANEK USA,INC. TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) 08/07/1995
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
K130267 SPINEART ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM 05/31/2013
K101678 SPINEART ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM 07/28/2010
K151695 SPINEART Romeo posterior osteosynthesis system 09/10/2015
K140948 SPINEART ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM 05/20/2014
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
K951626 SYNTHES (USA) SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM 08/21/1995
K962608 SYNTHES (USA) SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR 12/09/1996
K951794 SYNTHES (USA) SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM) 08/21/1995
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
K950074 WRIGHT MEDICAL TECHNOLOGY, INC. WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM 08/11/1995
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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact