Orthosis, Spondylolisthesis Spinal Fixation
The Orthosis, Spondylolisthesis Spinal Fixation is an orthopedic implant used to stabilize the spine in patients with spondylolisthesis, a condition where one vertebra slips forward over another. It is classified as FDA Class 2, requiring 510(k) premarket notification under 21 CFR 888.3070 in the Orthopedic specialty. The product code is MNH, and the device carries an implant flag indicating it is surgically placed within the body.
Basic Information
- Product Code
- MNH
- Device Class
- FDA class 2
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 309 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K162066 | Reliance Spinal Screw System | Dec 02, 2016 | Substantially Equivalent | Reliance Medical Systems, LLC |
| K162801 | CastleLoc Spinal Fixation System | Nov 03, 2016 | Substantially Equivalent | L&K BIOMED CO., LTD. |
| K162143 | FixxSure® X-Link | Sep 23, 2016 | Substantially Equivalent | INNOVASIS, INC. |
| K161151 | Spinal fixation system | Sep 21, 2016 | Substantially Equivalent | CANWELL MEDICAL CO., LTD. |
| K162189 | ANAX 5.5 Spinal System | Aug 30, 2016 | Substantially Equivalent | U&I Corporation |
| K151362 | HC Spinal System | May 05, 2016 | Substantially Equivalent | HUNG CHUN BIO-S CO., LTD. |
| K153404 | Zavation Spinal System | Apr 21, 2016 | Substantially Equivalent | ZAVATION, LLC |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System | Mar 02, 2016 | Substantially Equivalent | Captiva Spine |
| K143013 | Spinal Inner Fixation System | Dec 11, 2015 | Substantially Equivalent | Changzhou Dingjian Medical Appliance Co., Ltd |
| K151695 | Romeo posterior osteosynthesis system | Sep 10, 2015 | Substantially Equivalent | SPINEART |
| K151116 | CapLOX II/TowerLOX Pedicle Screw System | Jun 26, 2015 | Substantially Equivalent | CAPTIVA SPINE |
| K150283 | Republic Spine Dark Star Spinal System | Apr 29, 2015 | Substantially Equivalent | REPUBLIC SPINE, LLC |
| K142798 | PASS LP Spinal System | Mar 25, 2015 | Substantially Equivalent | MEDICREA INTERNATIONAL S.A. |
| K143417 | ANAX 5.5 Spinal System | Feb 25, 2015 | Substantially Equivalent | U&I Corporation |
| K143377 | PedFuse Pedicle Screw System | Feb 12, 2015 | Substantially Equivalent | SPINEFRONTIER, INC. |
| K142957 | Ideal pedicle screw spinal system | Jan 30, 2015 | Substantially Equivalent | JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD. |
| K142655 | CB PROT II Posterior Spinal System | Jan 26, 2015 | Substantially Equivalent | CHIN BONE TECHNIQUE CORP |
| K140359 | MAXIMIS SPINAL FIXATION SYSTEM | Jan 07, 2015 | Substantially Equivalent | VALOREM SURGICAL |
| K142290 | KangLi pedical screw spinal system | Nov 24, 2014 | Substantially Equivalent | SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD |
| K134011 | GENERAL SPINAL SYSTEM | Sep 03, 2014 | Substantially Equivalent | CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD |
| K133575 | SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM | Jun 30, 2014 | Substantially Equivalent | SPINEVISION, S.A. |
| K141376 | INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS | Jun 26, 2014 | Substantially Equivalent | NEXXT SPINE LLC |
| K140053 | KANGLI PEDICLE SCREW SPINAL SYSTEM | Jun 26, 2014 | Substantially Equivalent | SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD |
| K140678 | COSMOLOCK PEDICLE SCREW SYSTEM | Jun 19, 2014 | Substantially Equivalent | KALITEC DIRECT, LLC |
| K140787 | PLS (POSTERIOR LUMBAR SYSTEM) | May 30, 2014 | Substantially Equivalent | SINTEA PLUSTEK, LLC |
| K140948 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | May 20, 2014 | Substantially Equivalent | SPINEART |
| K133153 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM | May 14, 2014 | Substantially Equivalent | SPINEFRONTIER, INC. |
| K133690 | TRUE SPINAL FUSSION SYSTEM | May 07, 2014 | Substantially Equivalent | INNOVATIVE SURGICAL DESIGNS |
| K133287 | PRESSON SPINAL FIXATION SYSTEM | Feb 25, 2014 | Substantially Equivalent | NEXUS SPINE, LLC |
| K132403 | ANNEXTM ADJACENT LEVEL SYSTEM | Jan 10, 2014 | Substantially Equivalent | SPINE WAVE, INC. |
| K132218 | PERFIX ILIAC SCREW SYSTEM | Dec 17, 2013 | Substantially Equivalent | U & I CORPORATION |
| K132101 | ANAX 5.5 SPINAL SYSTEM | Nov 25, 2013 | Substantially Equivalent | U & I CORPORATION |
| K131810 | OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM | Aug 08, 2013 | Substantially Equivalent | OSSEUS FUSION SYSTEMS, LLC |
| K131538 | CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM | Aug 08, 2013 | Substantially Equivalent | CAPTIVA SPINE |
| K130267 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | May 31, 2013 | Substantially Equivalent | SPINEART |
| K122994 | INTRAMEDULLARY NAIL SYSTEM | Apr 12, 2013 | Substantially Equivalent | WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
| K123487 | GSO GS1 CANNULATED SCREW SYSTEM | Mar 11, 2013 | Substantially Equivalent | GOLD STANDARD ORTHOPAEDICS, LLC |
| K123164 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM | Feb 15, 2013 | Substantially Equivalent | SPINEFRONTIER, INC. |
| K123476 | MEGA 5.5 SPINE SYSTEM | Jan 08, 2013 | Substantially Equivalent | LSK BIOPARTNERS, INC. |
| K122592 | INSTINCT JAVA SYSTEM | Jan 04, 2013 | Substantially Equivalent | ZIMMER SPINE |
| K122814 | GALLEON PEDICLE SCREW SYSTEM | Dec 03, 2012 | Substantially Equivalent | EVEREST SPINE, LLC |
| K120832 | FORTEX PEDICLE SCREW SYSTEM | Oct 23, 2012 | Substantially Equivalent | X-SPINE SYSTEMS, INC |
| K121016 | RANGE SPINAL SYSTEM (MESA AND DENALI) | Jun 27, 2012 | Substantially Equivalent | K2M, INC. |
| K120760 | LDR SPINE SPINETUNE TL SPINAL SYSTEM | Jun 27, 2012 | Substantially Equivalent | LDR SPINE USA INC. |
| K111940 | S 100 PEDICLE SCREW SYSTEM | May 15, 2012 | Substantially Equivalent | RENOVIS SURGICAL TECHNOLOGIES, LLC |
| K120491 | DSS STABILIZATION SYSTEM-RIGID | May 09, 2012 | Unknown | PARADIGM SPINE, LLC |
| K120353 | SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM | May 09, 2012 | Substantially Equivalent | BM KOREA CO., LTD. |
| K103573 | ARTS2 SPINAL FIXATION SYSTEM | Dec 28, 2011 | Substantially Equivalent | ADVANCED MEDICAL TECHNOLOGIES |
| K110633 | LANCER PEDICLE SCREW SYSTEM | Dec 15, 2011 | Substantially Equivalent | SPINAL SOLUTIONS, LLC |
| K111995 | XINGTM SPINE SYSTEM | Dec 12, 2011 | Substantially Equivalent | IMPLANOVA CO. LTD |
| K111690 | DEVINE SPINAL SYSTEM | Nov 22, 2011 | Substantially Equivalent | CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. |
| K110497 | PASS LP SPINAL SYSTEM | Sep 26, 2011 | Substantially Equivalent | MEDICREA INTERNATIONAL |
| K111370 | ODALYS PEDICLE SCREW SYSTEM | Sep 21, 2011 | Substantially Equivalent | KALITEC DIRECT, LLC |
| K111362 | REXIOUS SPINAL FIXATION SYSTEM | Jul 21, 2011 | Substantially Equivalent | DIO MEDICAL CO., LTD. |
| K102458 | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM | Jun 13, 2011 | Substantially Equivalent | SOLCO BIOMEDICAL CO., LTD. |
| K110321 | TIGER SPINE SYSTEM | May 25, 2011 | Substantially Equivalent | CORELINK, LLC |
| K101374 | AAXTER A3 POSTERIOR SPINAL SYSTEM | Mar 16, 2011 | Substantially Equivalent | AAXTER CO., LTD |
| K102574 | PALLA M SPINAL SYSTEM | Mar 07, 2011 | Substantially Equivalent | KOREA BONE BANK CO., LTD |
| K102636 | ZENITH PEDICLE SYSTEM | Mar 03, 2011 | Substantially Equivalent | APOLLO SPINE, INC. |
| K101818 | 4CIS VANE SPINE SYSTEM | Feb 11, 2011 | Substantially Equivalent | SOLCO BIOMEDICAL CO., LTD. |
| K103085 | VENUS BASIC SPINAL FIXATION SYSTEM | Feb 09, 2011 | Substantially Equivalent | L&K BIOMED CO., LTD |
| K102853 | FLAMENCO SPINAL FIXATION SYSTEM | Jan 25, 2011 | Substantially Equivalent | ULRICH GMBH & CO. KG |
| K102870 | EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM | Jan 21, 2011 | Substantially Equivalent | EXACTECH, INC. |
| K101446 | EMERALD SPINAL SYSTEM | Jan 20, 2011 | Substantially Equivalent | MAZOR SURGICAL TECHNOLOGIES LTD. |
| K101278 | INERTIA PEDICLE SCREW SYSTEM | Dec 20, 2010 | Substantially Equivalent | NEXXT SPINE LLC |
| K102488 | APEX SPINE SYSTEM W/ COCR RODS | Dec 10, 2010 | Substantially Equivalent | SPINECRAFT LLC |
| K093771 | QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM | Aug 10, 2010 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K101678 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | Jul 28, 2010 | Substantially Equivalent | SPINEART |
| K100706 | VENUS BASIC SPINAL FIXATION SYSTEM | Jul 22, 2010 | Substantially Equivalent | L & K BIOMED CO., LTD |
| K100956 | SPONDY SPINAL FIXATION SYSTEM | Jul 09, 2010 | Substantially Equivalent | ALLURE SPINE L.L.C. |
| K100373 | TYCHE PEDICLE SCREW SYSTEM | Jun 30, 2010 | Substantially Equivalent | KYUNGWON MEDICAL CO., LTD. |
| K100605 | MIS SYSTEM | Jun 04, 2010 | Substantially Equivalent | SPINE WAVE, INC. |
| K093670 | MODIFICATION TO: OASYS SYSTEM | Mar 18, 2010 | Substantially Equivalent | STRYKER SPINE |
| K100122 | MODIFICATION TO CAPSURE PS SYSTEM | Feb 12, 2010 | Substantially Equivalent | SPINE WAVE, INC. |
| K091725 | PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) | Nov 09, 2009 | Substantially Equivalent | U&I CORP. |
| K092011 | NORM SPINAL SYSTEM | Oct 28, 2009 | Substantially Equivalent | NORM TIBBI URUNLER ITHALAT IHRACAT SANAYI VE TICAR |
| K083077 | ULC SPINAL PEDICLE SCREW SYSTEM | Oct 26, 2009 | Substantially Equivalent | OTIS BIOTECH CO., LTD |
| K083567 | GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW | Sep 14, 2009 | Substantially Equivalent | CO-LIGNE AG |
| K090224 | FORTEX PEDICLE SCREW SYSTEM | Jul 30, 2009 | Substantially Equivalent | X-SPINE SYSTEMS, INC. |
| K090477 | ALPINE PEDICLE SCREW SYSTEM | Jul 27, 2009 | Substantially Equivalent | SANACOR |
| K091110 | SPINAL EDGE TITAN PEDICLE SCREW SYSTEM | Jul 24, 2009 | Substantially Equivalent | SPINAL EDGE, LLC |
| K090424 | DVX SPINE SYSTEM | May 14, 2009 | Substantially Equivalent | BK MEDITECH CO., LTD. |
| K090228 | ROC LUMBAR PLATING SYSTEM | Apr 29, 2009 | Substantially Equivalent | ALPHATEC SPINE, INC. |
| K083581 | LANX SPINAL FIXATION SYSTEM | Apr 07, 2009 | Substantially Equivalent | LANX, INC. |
| K080611 | MESA SPINAL SYSTEM | Mar 04, 2009 | Substantially Equivalent | K2M, INC. |
| K081153 | NOVEL SPINAL SYSTEM | Jan 30, 2009 | Substantially Equivalent | MEDYSSEY CO., LTD. |
| K083826 | LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM | Jan 22, 2009 | Substantially Equivalent | ALLEZ SPINE, LLC |
| K081165 | ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM | Dec 17, 2008 | Substantially Equivalent | SPINEART |
| K082509 | EOS SPINAL SYSTEM | Dec 15, 2008 | Substantially Equivalent | KOREA BONE BANK CO., LTD |
| K082577 | PASS LP SPINAL SYSTEM | Oct 03, 2008 | Substantially Equivalent | MEDICREA TECHNOLOGIES |
| K081883 | MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM | Sep 24, 2008 | Substantially Equivalent | US SPINE |
| K082453 | 4CIS SOLAR AND APOLLON SPINE SYSTEMS | Sep 23, 2008 | Substantially Equivalent | SOLCO BIOMEDICAL CO., LTD. |
| K081331 | FIXXSURE CROSS LINK | Jul 23, 2008 | Substantially Equivalent | SPINEWORKS, LLC |
| K081631 | SINTEA BIOTECH PLS MULTI-AXIAL SCREWS | Jul 18, 2008 | Substantially Equivalent | SINTEA BIOTECH, INC. |
| K081041 | GPS, G SURGICAL PEDICLE SYSTEM | Jun 27, 2008 | Substantially Equivalent | G SURGICAL CO., LTD. |
| K080828 | MOUNTAINEER OCT SPINAL SYSTEM | Jun 27, 2008 | Substantially Equivalent | DEPUY SPINE, INC. |
| K081381 | RANGE SPINAL SYSTEM, LARGE DENALI SCREWS | Jun 13, 2008 | Substantially Equivalent | K2M, INC. |
| K081296 | PREFERENCE PEDICLE SCREW SYSTEM | Jun 06, 2008 | Substantially Equivalent | US SPINE |
| K080876 | DVX SPINE SYSTEM | Jun 04, 2008 | Substantially Equivalent | BK MEDITECH CO., LTD. |
| K073531 | ACCIN PEDICLE SCREW SYSTEM | Feb 04, 2008 | Substantially Equivalent | ACCELERATED INNOVATION, LLC |
| K071890 | ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM | Nov 09, 2007 | Substantially Equivalent | ALPHATEC SPINE, INC. |
| K070530 | MODIFICATION TO PASSMED SPINAL SYSTEM | Oct 18, 2007 | Substantially Equivalent | MEDICREA TECHNOLOGIES |
| K072282 | CAPLESS LI PEDICLE SCREW SYSTEM | Sep 14, 2007 | Substantially Equivalent | X-SPINE SYSTEMS, INC. |
| K070933 | LOWTOP PEDICLE SCREW SYSTEM | Jun 13, 2007 | Substantially Equivalent | SANACOR |
| K062670 | VERTIFLEX SPINAL SCREW SYSTEM | Jan 12, 2007 | Substantially Equivalent | VERTIFLEX (TM), INCORPORATED |
| K062174 | MODIFICATION TO EXPEDIUM SPINE SYSTEM | Nov 02, 2006 | Substantially Equivalent | DEPUY SPINE, INC. |
| K061524 | ISS INTEGRATED SPINE SYSTEM | Sep 26, 2006 | Substantially Equivalent | ORTHO DEVELOPMENT CORP. |
| K061813 | MANTIS SPINAL SYSTEM | Sep 19, 2006 | Substantially Equivalent | STRYKER SPINE |
| K061577 | OVALTWIST PEDICLE SCREW SYSTEM | Sep 14, 2006 | Substantially Equivalent | SIGNUS MEDIZINTECHNIK GMBH |
| K062196 | SFX SNAP-FIT CROSS CONNECTOR | Sep 11, 2006 | Substantially Equivalent | DEPUY SPINE, INC. |
| K061364 | PILOT POSTERIOR LUMBAR PLATING SYSTEM | Sep 05, 2006 | Substantially Equivalent | LIFE SPINE |
| K062317 | MODIFICATION TO NUVASIVE SPHERX II SYSTEM | Sep 01, 2006 | Substantially Equivalent | NUVASIVE, INC. |
| K061162 | BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 | Jul 26, 2006 | Substantially Equivalent | APPLIED SPINE TECHNOLOGIES, INC. |
| K061915 | CD HORIZON SPINAL SYSTEM | Jul 25, 2006 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K061441 | EBI 5.5 HELICAL FLANGE SPINAL SYSTEM | Jul 25, 2006 | Substantially Equivalent | EBI, L.P. |
| K061778 | NUVASIVE SPHERX II SYSTEM | Jul 18, 2006 | Substantially Equivalent | NUVASIVE, INC. |
| K053623 | NFIX FUSION SYSTEM | Jul 12, 2006 | Substantially Equivalent | N-SPINE, INC. |
| K061321 | ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX | Jul 07, 2006 | Substantially Equivalent | ALPHATEC SPINE, INC. |
| K060702 | 4CIS VANE SPINE SYSTEM | Jun 22, 2006 | Substantially Equivalent | SOLCO BIOMEDICAL CO., LTD. |
| K060118 | SSP PEDICLE SCREW SYSTEM | Jun 08, 2006 | Substantially Equivalent | SPECIALTY SPINE PRODUCTS, LLC |
| K060225 | NUVASIVE SPHERX SYSTEM | Apr 12, 2006 | Substantially Equivalent | NUVASIVE, INC. |
| K053573 | GSS PEDICLE SCREW SYSTEM | Mar 08, 2006 | Substantially Equivalent | GS MEDICAL CO., LTD. |
| K053070 | CONTOUR II SPINAL SYSTEM | Feb 13, 2006 | Substantially Equivalent | ALTIVA CORP. |
| K051089 | GII SPINAL FIXATION SYSTEM | Oct 26, 2005 | Substantially Equivalent | CO-LIGNE AG |
| K051959 | NV CORMED SOLAS SPINAL SYSTEM | Oct 12, 2005 | Substantially Equivalent | NV CORMED |
| K051044 | ARCTEC SEMIRIGID PLATING SYSTEM | Oct 07, 2005 | Substantially Equivalent | ALTIVA CORP. |
| K051697 | SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM | Sep 21, 2005 | Substantially Equivalent | MEDICAL DEVICE ADVISORY DEVELOPMENT GROUP |
| K050461 | XIA 4.5 SPINAL SYSTEM | Jul 27, 2005 | Substantially Equivalent | STRYKER SPINE |
| K051216 | HYDRALOK SYSTEM | Jul 19, 2005 | Substantially Equivalent | ALTIVA CORP. |
| K051286 | ZODIAC SPINAL FIXATION SYSTEM | Jun 17, 2005 | Substantially Equivalent | ALPHATEC/NEXMED |
| K050471 | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM | May 12, 2005 | Substantially Equivalent | SOLCO BIOMEDICAL CO., LTD. |
| K043578 | THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM | Mar 07, 2005 | Substantially Equivalent | SOLCO BIOMEDICAL CO., LTD. |
| K043180 | STRYKER SPINE TRIO PS | Mar 02, 2005 | Substantially Equivalent | STRYKER SPINE |
| K050078 | ROC LUMBAR PLATING SYSTEM | Feb 18, 2005 | Substantially Equivalent | ALPHATEC/NEXMED |
| K042928 | MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM | Feb 17, 2005 | Substantially Equivalent | U&I CORP. |
| K043152 | VERTEBRON PSS PEDICLE SCREW SYSTEM | Feb 01, 2005 | Substantially Equivalent | VERTEBRON, INC. |
| K043343 | MODIFICATION TO: CD HORIZON SPINAL SYSTEM | Dec 28, 2004 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K043001 | MX POLYAXIAL PEDICLE SCREW | Dec 01, 2004 | Substantially Equivalent | SCIENT'X |
| K042640 | UNI-THREAD SPINAL SYSTEM | Nov 23, 2004 | Substantially Equivalent | SPINEVISION, INC. |
| K042964 | MX MONOAXIAL PEDICLE SCREW | Nov 22, 2004 | Substantially Equivalent | SCIENT'X |
| K040747 | ALADYN RIGID SPINE PLATE | Jun 17, 2004 | Substantially Equivalent | SCIENT'X |
| K033512 | PROCYON SPINAL SYSTEM | Jun 03, 2004 | Substantially Equivalent | NAS MEDICAL TECHNOLOGIES, INC. |
| K040442 | PROTEX STABILIZATION SYSTEM | May 20, 2004 | Substantially Equivalent | GLOBUS MEDICAL, INC. |
| K034056 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Apr 21, 2004 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K033546 | NUVASIVE SPINAL SYSTEM | Apr 12, 2004 | Substantially Equivalent | NUVASIVE, INC. |
| K040072 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Feb 12, 2004 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K032604 | GII SPINAL FIXATION SYSTEM | Jan 20, 2004 | Substantially Equivalent | CO-LIGNE AG |
| K033322 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Dec 15, 2003 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K032855 | STRYKER SPINE MAPS SYSTEM | Dec 10, 2003 | Substantially Equivalent | HOWMEDICA OSTEONICS |
| K031265 | SHIRAZ-JAVA SPINAL FIXATION SYSTEM | Oct 09, 2003 | Substantially Equivalent | SPINE NEXT SA |
| K031585 | U&I, OPTIMA, SPINAL SYSTEM | Jun 27, 2003 | Substantially Equivalent | U&I CORP., AMERICA |
| K031423 | EBI P148 SPINAL FIXATION SYSTEM | Jun 27, 2003 | Substantially Equivalent | EBI, L.P. |
| K023378 | ORIA CLARIS | Jun 27, 2003 | Substantially Equivalent | ORTHOTEC, L.L.C. |
| K030581 | BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) | Jun 26, 2003 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K031290 | MODIFICATION TO EASYS TRANSVERSE CONNECTION | May 13, 2003 | Substantially Equivalent | SCIENT'X USA, INC. |
| K030383 | MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS | Feb 26, 2003 | Substantially Equivalent | DEPUY ACROMED |
| K023994 | ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ | Feb 05, 2003 | Substantially Equivalent | ORTHOTEC, L.L.C. |
| K024348 | MONARCH SPINE SYSTEM | Jan 28, 2003 | Substantially Equivalent | DEPUY ACROMED |
| K020085 | SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X | Dec 10, 2002 | Substantially Equivalent | SINTEA BIOTECH, INC. |
| K023438 | MODIFICATION TO MONARCH SPINE SYSTEM | Nov 13, 2002 | Substantially Equivalent | DEPUY ACROMED |
| K023204 | MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM | Oct 18, 2002 | Substantially Equivalent | EBI, L.P. |
| K021623 | UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS | Sep 10, 2002 | Substantially Equivalent | IAME, INC. |
| K021881 | ENDIUS TITLE SPINAL FIXATION SYSTEM | Jul 29, 2002 | Substantially Equivalent | ENDIUS, INC. |
| K020356 | ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM | Jul 23, 2002 | Substantially Equivalent | ALPHATEC MFG., INC. |
| K020247 | COLORADO 2 SPINAL SYSTEM | Jul 22, 2002 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K021335 | MONARCH SPINE SYSTEM | Jul 11, 2002 | Substantially Equivalent | DEPUY ACROMED |
| K021880 | CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM) | Jun 26, 2002 | Substantially Equivalent | DEPUY ACROMED |
| K021879 | CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) | Jun 26, 2002 | Substantially Equivalent | DEPUY ACROMED |
| K013962 | EQUATION FIXATION SYSTEM | Jun 20, 2002 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K020699 | TSRH SPINAL SYSTEM | May 28, 2002 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K021148 | MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD | May 08, 2002 | Substantially Equivalent | DEPUY ACROMED |
| K020681 | EBI OMEGA21 SPINAL FIXATION SYSTEM | Apr 03, 2002 | Substantially Equivalent | EBI, L.P. |
| K020674 | BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW | Apr 03, 2002 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K014302 | UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM | Mar 29, 2002 | Substantially Equivalent | PISHARODI SURGICALS, INC. |
| K020196 | MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM | Feb 15, 2002 | Substantially Equivalent | SULZER SPINE-TECH |
| K020293 | OSTEONICS SPINAL SYSTEM | Feb 14, 2002 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K013887 | BACFIX SPINAL FIXATION SYSTEM | Feb 12, 2002 | Substantially Equivalent | SPINAL CONCEPTS, INC. |
| K020245 | MODIFICATION TO ISOBAR SPINAL SYSTEM | Feb 01, 2002 | Substantially Equivalent | SCIEN'TX USA INC. |
| K014229 | MODIFICATION TO OPUS SPINAL SYSTEM | Jan 25, 2002 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K014137 | MODIFICATION TO EBI OMEGA 21 SYSTEM | Jan 16, 2002 | Substantially Equivalent | EBI, L.P. |
| K014076 | MODIFICATION TO TSRH SPINAL SYSTEM | Dec 27, 2001 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K013688 | MODIFICATION TO XIA SPINAL SYSTEM | Dec 05, 2001 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K013444 | ISOBAR SPINAL SYSTEM | Nov 16, 2001 | Substantially Equivalent | SCIEN'TX USA INC. |
| K013296 | MOSS MIAMI SPINAL SYSTEMS | Oct 09, 2001 | Substantially Equivalent | DEPUY ACROMED |
| K013295 | TIMX SPINAL SYSTEMS | Oct 09, 2001 | Substantially Equivalent | DEPUY ACROMED |
| K013294 | MONARCH SPINAL SYSTEMS | Oct 09, 2001 | Substantially Equivalent | DEPUY ACROMED |
| K012971 | ISOLA SPINAL SYSTEMS | Oct 05, 2001 | Substantially Equivalent | DEPUY ACROMED |
| K012273 | SPIRAL RADIUS 90-D SST SYSTEM | Aug 15, 2001 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K012027 | MODIFICATION TO XIA SPINE SYSTEM | Jul 20, 2001 | Substantially Equivalent | HOWMEDICA OSTEONICS |
| K003733 | SCS CLOSED SCREW | May 29, 2001 | Substantially Equivalent | ORTHOTEC, L.L.C. |
| K011182 | MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS | May 16, 2001 | Substantially Equivalent | DEPUY ACROMED |
| K010369 | CLARIS PLATE SYSTEM | May 08, 2001 | Substantially Equivalent | ORTHOTEC, L.L.C. |
| K010845 | MODIFICATION TO OSTEONICS SPINAL SYSTEM | Apr 18, 2001 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K010742 | MOSS MIAMI 5.5MM TITANIUM PIN NUT | Apr 12, 2001 | Substantially Equivalent | DEPUY ACROMED |
| K010720 | TSRH SPINAL SYSTEM | Apr 11, 2001 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K003463 | SOCON SPINAL SYSTEM | Apr 11, 2001 | Substantially Equivalent | AESCULAP, INC. |
| K010776 | TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS | Apr 06, 2001 | Substantially Equivalent | CORIN U.S.A. |
| K010535 | TRIFIX SPINAL FIXATION SYSTEM | Mar 19, 2001 | Substantially Equivalent | ENDIUS, INC. |
| K010249 | CD HORIZON SPINAL SYSTEM | Feb 23, 2001 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K003764 | MODIFICATION TO EBI SPINELINK SYSTEM | Jan 02, 2001 | Substantially Equivalent | EBI, L.P. |
| K000641 | CD HORIZON SPINAL SYSTEM | Dec 22, 2000 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K003490 | OPUS ROD FIXATION SYSTEM | Dec 08, 2000 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K003384 | VERSALINK TITANIUM ROD-TO-ROD COUPLERS | Nov 24, 2000 | Substantially Equivalent | OSTEOTECH, INC. |
| K001044 | ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM | Nov 03, 2000 | Substantially Equivalent for Some Indications | ACME SPINE, LLC. |
| K001668 | GLOBAL SPINAL FIXATION SYSTEM | Oct 19, 2000 | Substantially Equivalent | D.K.M. CO.,LTD. |
| K002399 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Sep 27, 2000 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K001255 | CD HORIZON SPINAL SYSTEM | Jul 11, 2000 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K001066 | CD HORIZON ECLIPSE | Jun 22, 2000 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K001627 | TRIFIX SPINAL FIXATION SYSTEM | Jun 03, 2000 | Substantially Equivalent | ENDIUS, INC. |
| K001319 | XIA SPINE SYSTEM HOOKS | May 23, 2000 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K001024 | PASS SPINAL SYSTEM | May 23, 2000 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K991031 | COLORADO II SPINAL SYSTEM | May 10, 2000 | Substantially Equivalent | SOFAMOR DANEK USA,INC. |
| K993503 | HAIDER-UCR SPINAL SYSTEM | Apr 14, 2000 | Substantially Equivalent | INTERNATIONAL ADVANCED MEDICAL ENTERPRISES, INC. |
| K994288 | 5.0MM SPINAL SCREWS | Apr 10, 2000 | Substantially Equivalent | ORTHOTEC, L.L.C. |
| K984360 | COLORADO II SPINAL SYSTEM | Mar 30, 2000 | Substantially Equivalent | SOFAMOR DANEK USA,INC. |
| K000476 | MODIFICATION TO CD SPINAL SYSTEM | Mar 10, 2000 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K000453 | MODIFICATION TO CD SPINAL SYSTEM | Mar 10, 2000 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K994217 | BLACKSTONE SPINAL FIXATION SYSTEM | Feb 28, 2000 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K992739 | CLICK'X | Feb 08, 2000 | Substantially Equivalent | SYNTHES SPINE |
| K000094 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Feb 08, 2000 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K993810 | CD HORIZON SPINAL SYSTEM | Feb 03, 2000 | Substantially Equivalent | DANEK MEDICAL, INC. |
| K000020 | MODIFICATION TO ISOBAR SPINAL SYSTEM | Feb 03, 2000 | Substantially Equivalent | ENCORE ORTHOPEDICS, INC. |
| K993551 | SOCON SPINAL SYSTEM | Jan 13, 2000 | Substantially Equivalent | AESCULAP, INC. |
| K993926 | OMNIAXIAL CONNECTOR | Dec 17, 1999 | Substantially Equivalent | ORTHOTEC, L.L.C. |
| K993808 | SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220 | Dec 06, 1999 | Substantially Equivalent | INTERPORE CROSS INTL. |
| K991036 | DANEK PLATE AND SCREW SYSTEM | Sep 14, 1999 | Substantially Equivalent | SOFAMOR DANEK USA,INC. |
| K991055 | OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM | Aug 27, 1999 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K991552 | SYNTHES PEDIATRIC ROD SYSTEM | Jun 02, 1999 | Substantially Equivalent | SYNTHES (USA) |
| K991528 | MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR | May 28, 1999 | Substantially Equivalent | DANEK MEDICAL, INC. |
| K990721 | ISOLOCK SPINAL SYSTEM | May 27, 1999 | Substantially Equivalent | SCIEN'TX USA INC. |
| K991460 | MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM | May 19, 1999 | Substantially Equivalent | SOFAMOR DANEK |
| K991364 | MODIFICATION TO TENOR SPINAL SYSTEM-PLATES | May 19, 1999 | Substantially Equivalent | SOFAMOR DANEK USA,INC. |
| K990657 | TRIFIX PEDICLE SPINAL SCREW ASSEMBLY | Mar 26, 1999 | Substantially Equivalent | CORIN U.S.A. |
| K990118 | ISOBAR SPINAL SYSTEM | Mar 22, 1999 | Substantially Equivalent | SCIEN'TX USA INC. |
| K984302 | OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS | Dec 18, 1998 | Substantially Equivalent | OSTEONICS CORP. |
| K983152 | OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS | Sep 25, 1998 | Substantially Equivalent | OSTEONICS CORP. |
| K980761 | SYNTHES SPINE PEDIATRIC ROD SYSTEM | Aug 04, 1998 | Substantially Equivalent | SYNTHES SPINE |
| K981714 | TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM | Jun 30, 1998 | Substantially Equivalent | ACROMED CORP. |
| K981113 | PEDIATRIC PRC | May 29, 1998 | Substantially Equivalent | ACROMED CORP. |
| K980862 | TITANIUM SPINAL ROD SYSTEM | May 20, 1998 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K980852 | GII SPINAL FIXATION SYSTEM | May 01, 1998 | Substantially Equivalent | KAREN E. WARDEN, M.E.B.E. |
| K981274 | ACROMED TIMX PLATE BASED LOW BACK SYSTEM | Apr 29, 1998 | Substantially Equivalent | ACROMED CORP. |
| K980496 | WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER | Apr 14, 1998 | Substantially Equivalent for Some Indications | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K980447 | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM | Apr 14, 1998 | Substantially Equivalent for Some Indications | DEPUY ORTHOPAEDICS, INC. |
| K973687 | SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM | Mar 18, 1998 | Substantially Equivalent for Some Indications | SPINAL CONCEPTS, INC. |
| K974749 | SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS | Mar 13, 1998 | Substantially Equivalent for Some Indications | CROSS MEDICAL PRODUCTS, INC. |
| K974734 | AURORA TITANIUM SPINAL ROD SYSTEM | Mar 10, 1998 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K973836 | SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM | Mar 05, 1998 | Substantially Equivalent for Some Indications | CROSS MEDICAL PRODUCTS, INC. |
| K973425 | THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM | Feb 27, 1998 | Substantially Equivalent | CORIN U.S.A. |
| K974213 | AURORA TITANIUM SPINAL ROD SYSTEM | Feb 04, 1998 | Substantially Equivalent for Some Indications | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K973683 | OMEGA 21 SYSTEM | Dec 24, 1997 | Substantially Equivalent for Some Indications | EBI ELECTRO BIOLOGY |
| K972568 | DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM | Sep 19, 1997 | Substantially Equivalent | DEPUY, INC. |
| K971970 | EBI SPINELINK SYSTEM | Aug 20, 1997 | Substantially Equivalent | ELECTRO-BIOLOGY, INC. |
| K970285 | AESUCLAP SOCON SPINAL SYSTEM | Jun 25, 1997 | Substantially Equivalent | AESCULAP, INC. |
| K970950 | EASY ROD | Jun 03, 1997 | Substantially Equivalent | ACROMED CORP. |
| K965102 | ACROMED PEDICLE SCREW | May 08, 1997 | Substantially Equivalent | ACROMED CORP. |
| K964533 | EBI SPINELINK SYSTEM | Apr 09, 1997 | Substantially Equivalent | ELECTRO-BIOLOGY, INC. |
| K965046 | ISOLA TWISTER CONNECTOR | Mar 14, 1997 | Substantially Equivalent for Some Indications | ACROMED CORP. |
| K963045 | SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM | Feb 13, 1997 | Substantially Equivalent | SYNTHES (USA) |
| K964544 | OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY | Feb 11, 1997 | Substantially Equivalent | OSTEONICS CORP. |
| K964304 | OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY | Jan 17, 1997 | Substantially Equivalent | OSTEONICS CORP. |
| K950099 | SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM | Jan 16, 1997 | Substantially Equivalent for Some Indications | BUCKMAN CO., INC. |
| K963357 | MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE | Jan 09, 1997 | Substantially Equivalent for Some Indications | SYNTHES (USA) |
| K964007 | ACROMED CABLE/WIRE PEDICLE SCREW | Dec 16, 1996 | Substantially Equivalent for Some Indications | ACROMED CORP. |
| K962608 | SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR | Dec 09, 1996 | Substantially Equivalent for Some Indications | SYNTHES (USA) |
| K962645 | ISOLA TWISTER CONNECTOR | Oct 22, 1996 | Substantially Equivalent | ACROMED CORP. |
| K962784 | ULTIUM SPINAL PLATING SYSTEM | Oct 02, 1996 | Substantially Equivalent for Some Indications | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
| K962757 | J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP | Sep 25, 1996 | Substantially Equivalent | J.B.S., S.A. |
| K961572 | VERSALOK SCREW ASSEMBLY (PROPOSED NAME) | Sep 17, 1996 | Substantially Equivalent for Some Indications | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K960107 | DDS SPINAL SYSTEM | May 03, 1996 | Substantially Equivalent for Some Indications | ENCORE ORTHOPEDICS, INC. |
| K960451 | WEBB-MORLEY SPINE SYSTEM | Apr 18, 1996 | Substantially Equivalent for Some Indications | BUCKMAN CO., INC. |
| K953881 | SPINE SYSTEM SACRAL PLATE | Feb 21, 1996 | Substantially Equivalent for Some Indications | J.B.S., S.A. |
| K953915 | MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE) | Feb 15, 1996 | Substantially Equivalent for Some Indications | DEPUY, INC. |
| K950717 | AUGMENT-T POSTERIOR SPINAL SYSTEM | Feb 14, 1996 | Substantially Equivalent for Some Indications | SOFAMOR DANEK USA,INC. |
| K943827 | SPINE FIXATION | Feb 14, 1996 | Substantially Equivalent for Some Indications | DANEK MEDICAL, INC. |
| K950999 | KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS | Jan 25, 1996 | Substantially Equivalent | BUCKMAN CO., INC. |
| K952236 | ISOLA SYSTEM | Jan 22, 1996 | Substantially Equivalent for Some Indications | ACROMED CORP. |
| K952298 | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE | Dec 13, 1995 | Substantially Equivalent for Some Indications | J.B.S., S.A. |
| K951266 | AMSET R-F SYSTEM | Nov 21, 1995 | Substantially Equivalent for Some Indications | ADVANCED SPINE TECHNOLOGY, INC. |
| K953779 | SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM | Nov 07, 1995 | Substantially Equivalent for Some Indications | ADVANCED SPINE FIXATION SYSTEMS, INC. |
| K953778 | SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM | Nov 06, 1995 | Substantially Equivalent for Some Indications | ADVANCED SPINE FIXATION SYSTEMS, INC. |
| K953635 | TITANIUM DYNA-LOK SPINAL SYSTEM | Oct 30, 1995 | Substantially Equivalent for Some Indications | SOFAMOR DANEK USA,INC. |
| K953416 | BRYAN POSTERIOR SPINAL FIXATOR (BPSF) | Oct 03, 1995 | Substantially Equivalent for Some Indications | ARCAN ORTHOPAEDIC CORP. |
| K953369 | STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW | Sep 08, 1995 | Substantially Equivalent for Some Indications | ADVANCED SPINE FIXATION SYSTEMS, INC. |
| K951725 | OSTEONICS SPINAL SYSTEM | Sep 08, 1995 | Substantially Equivalent | OSTEONICS CORP. |
| K950865 | ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLT | Sep 01, 1995 | Substantially Equivalent for Some Indications | SMITH & NEPHEW RICHARDS, INC. |
| K950596 | GDLH POSTERIOR SPINAL SYSTEM | Aug 28, 1995 | Substantially Equivalent for Some Indications | SOFAMOR DANEK USA,INC. |
| K950955 | PARAGON POSTERIOR SPINAL SYSTEM | Aug 25, 1995 | Substantially Equivalent for Some Indications | SOFAMOR DANEK USA,INC. |
| K951794 | SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM) | Aug 21, 1995 | Substantially Equivalent for Some Indications | SYNTHES (USA) |
| K951657 | VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S) | Aug 21, 1995 | Substantially Equivalent for Some Indications | ACROMED CORP. |
| K951626 | SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM | Aug 21, 1995 | Substantially Equivalent for Some Indications | SYNTHES (USA) |
| K936307 | DYNA-LOK ANTERIOR PLATING SYSTEM | Aug 14, 1995 | Substantially Equivalent for Some Indications | DANEK GROUP, INC. |
| K951116 | ACROMED PEDICLE SCREW | Aug 11, 1995 | Substantially Equivalent for Some Indications | ACROMED CORP. |
| K950074 | WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM | Aug 11, 1995 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K946348 | TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) | Aug 07, 1995 | Substantially Equivalent for Some Indications | SOFAMOR DANEK USA,INC. |
| K951308 | 5.8MM DIAMETER ANCHOR SCREW | Jul 26, 1995 | Substantially Equivalent for Some Indications | ADVANCED SPINE FIXATION SYSTEMS, INC. |
| K951172 | TITANIUM LOW PROFILE CROSS BAR | Jul 25, 1995 | Substantially Equivalent | ADVANCED SPINE FIXATION SYSTEMS, INC. |
| K950695 | DEPUY MOTECH MOSS SPINAL SYSTEM - PEDICLE FIXATION | Jul 21, 1995 | Substantially Equivalent for Some Indications | DEPUY MOTECH |
| K940631 | CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM | Jul 13, 1995 | Substantially Equivalent for Some Indications | CROSS MEDICAL PRODUCTS, INC. |
| K950697 | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION | Jun 22, 1995 | Substantially Equivalent | DEPUY MOTECH |
| K944737 | ISOLA SPINE SYSTEM | Jun 22, 1995 | Substantially Equivalent | ACROMED CORP. |
| K930353 | SIMMONS PLATING SYSTEM BOLT AND SCREW | Jun 20, 1995 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K930298 | ROGOZINSKI SPINAL ROD SYSTEM SCREW | Jun 14, 1995 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K944756 | ISOLA OPEN AND CLOSED SCREWS | May 30, 1995 | Substantially Equivalent for Some Indications | ACROMED CORP. |
| K944736 | VSP (VARIABLE SCREW PLACEMENT) | May 05, 1995 | Substantially Equivalent | ACROMED CORP. |
| K945064 | SELBY INSTRUMENTATION | Apr 26, 1995 | Substantially Equivalent | ADVANCED SPINE FIXATION SYSTEMS, INC. |
| K943775 | SELBY INSTRUMENTATION | Apr 26, 1995 | Substantially Equivalent for Some Indications | ADVANCED SPINE FIXATION SYSTEMS, INC. |
| K942387 | SELBY INSTRUMENTATION | Feb 14, 1995 | Substantially Equivalent for Some Indications | ADVANCED SPINE FIXATION SYSTEMS, INC. |
| K932029 | TSRH SPINAL SCREWS | Jan 20, 1995 | Substantially Equivalent | SOFAMOR DANEK MFG., INC. |
FEI Numbers
This FDA classification entry is associated with 338 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 338 registration numbers. Click on an entry to view related FDA registrations.