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MNI

303 FDA 510(k) clearances · Product code

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RecordFirmDate
SHIRAZ-JAVA SPINAL FIXATION SYSTEM (K033772)Spine Next America2004-01-27
POSTERIOR CABLE SCREW (K022908)Pioneer Surgical Technology2004-01-22
REVOLUTION SPINAL FIXATION SYSTEM (K032219)Spinal Innovations, Inc.2003-12-19
MODIFICATION TO EQUATION FIXATION SYSTEM (K033495)Medtronic Sofamor Danek, Inc.2003-12-03
UCR SPINAL SYSTEM (K032739)Seaspine2003-11-20
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS (K030958)Ortho Tec, LLC2003-11-20
DYNALOK CLASSIC SPINAL SYSTEM (K033271)Medtronic Sofamor Danek2003-11-06
PLUS PIVOT LINK UNIVERSAL SYSTEM (K032398)Spine Vision, Inc.2003-10-31
CONKLUSION PEDICLE SCREW SYSTEM (K031455)Signus Medical, LLC2003-10-22
TSRH SPINAL SYSTEM (K032578)Medtronic Sofamor Danek, Inc.2003-09-17
TSRH SPINAL SYSTEM (K031967)Medtronic Sofamor Danek, Inc.2003-09-17
SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM (K031985)Spinal Concepts, Inc.2003-09-11
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) (K032037)Medtronic Sofamor Danek2003-09-04
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K031833)Medtronic Sofamor Danek2003-09-03
MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM (K024313)Pisharodi Surgicals, Inc.2003-08-29
EBI OMEGA21 SPINAL FIXATION SYSTEM (K031354)Ebi, L.P.2003-08-06
UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS (K031381)Seaspine2003-07-30
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K031888)Medtronic Sofamor Danek2003-06-27
CD HORIZON SPINAL SYSTEM (K031655)Medtronic Sofamor Danek USA, Inc.2003-06-27
CD HORIZON SPINAL SYSTEM (K030932)Medtronic Sofamor Danek, Inc.2003-05-16
MODIFICATION TO HORIZON SPINAL SYSTEM (K030840)Medtronic Sofamor Danek, Inc.2003-05-15
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR (K030862)Blackstone Medical, Inc.2003-04-17
SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS (K022949)Synthes (Usa)2003-03-24
OPTIMA, SPINAL SYSTEM (K024096)U&I Corp., America2003-03-12
MODIFICATION TO SYNTHES CERVIFIX SYSTEM (K030377)Synthes (Usa)2003-03-06
SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS (K030103)Depuyacromed2003-02-05
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM (K023299)Alphatec Mfg., Inc.2002-12-11
MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM (K023644)Spinal Concepts, Inc.2002-11-25
AMT POLYAXIAL PEDICLE SCREW (K022768)Micron Precision Engineering, Inc.2002-11-13
PLUS PIVOT LINK UNIVERSAL SYSTEM (K022271)Spine Vision, Inc.2002-09-23
MODIFICATION TO TSRH SPINAL SYSTEM (K022778)Medtronic Sofamor Danek, Inc.2002-09-18
MODIFICATION TO ISOLA SPINAL SYSTEM (K022285)Depuyacromed2002-08-13
XIA SPINAL SYSTEM (K022160)Howmedica Osteonics2002-08-01
UNI-T UNI-THREAD SPINAL SYSTEM (K021510)Spine Vision, Inc.2002-08-01
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM (K022190)Depuyacromed2002-07-24
MICOMED POSTERIOR DOUBLEROD SYSTEM (K021275)Micomed Ortho GmbH2002-07-18
FOREX CORPORATION, OPTIMA, SPINAL SYSTEM (K020279)Forex Corp.2002-06-20
SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 (K021379)Ortho Tec, LLC2002-05-31
MODIFICATION TO TSRH SPINAL SYSTEM (K021106)Medtronic Sofamor Danek, Inc.2002-05-03
SYNTHES DUAL-OPENING USS (K020517)Synthes (Usa)2002-04-15
UNI-T SPINAL SYSTEM (K013301)Spine Vision, Inc.2002-02-13
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS (K013885)Blackstone Medical, Inc.2002-02-01
ISOBAR SPINAL SYSTEM (K013440)Scien'Tx USA, Inc.2001-11-16
PASS SPINAL SYSTEM (K013431)Encore Orthopedics, Inc.2001-11-15
TRI-FIX SPINAL FIXATION SYSTEM (K013403)Endius, Inc.2001-11-14
SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM (K013222)Depuyacromed2001-11-07
PASS SPINAL SYSTEM (K013191)Encore Orthopedics, Inc.2001-10-24
SCS CLARIS SPINAL SCREWS, TYPES V,G,E (K011807)Ortho Tec, LLC2001-08-07
PASS SPINAL SYSTEM (K012175)Encore Orthopedics, Inc.2001-07-31
ISOLA BAND CLAMP (K010972)Depuyacromed2001-06-12
USS-LINE EXTENSION (K010108)Synthes2001-06-06
TRI-FIX SPINAL FIXATION SYSTEM (K010903)Endius, Inc.2001-06-06
TRI-FIX SPINAL FIXATION SYSTEM (K010922)Endius, Inc.2001-06-06
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS (K011437)Interpore Cross Intl.2001-06-06
MODIFICATION TO TSRH SPINAL SYSTEM (K011029)Medtronic Sofamor Danek, Inc.2001-06-05
MODIFIED USS FRACTURE SYSTEM (K010658)Synthes (Usa)2001-06-04
END-TO-END AND SIDE-BY-SIDE CONNECTORS (K010563)Spinal Concepts, Inc.2001-05-25
MONARCH SPINE SYSTEM (K010576)Depuyacromed2001-05-23
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR (K003735)Blackstone Medical, Inc.2001-05-08
MODIFICATION TO TSRH SPINAL SYSTEM (K011067)Medtronic Sofamor Danek, Inc.2001-05-04
SMALL STATURE USS (K994121)Synthes (Usa)2000-10-17
TRI-FIX SPINAL FIXATION SYSTEM (K000766)Endius, Inc.2000-06-01
MULTI-AXIAL CROSS (MAC) CONNECTOR (K000965)Howmedica Osteonics Corp.2000-05-11
MODIFICATION TO TSRH SPINAL SYSTEM (K000991)Medtronic Sofamor Danek, Inc.2000-04-18
SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP (K000876)Interpore Cross Intl.2000-04-18
MODIFICATION TO EBI SPINELINK SYSTEM (K001037)Ebi, L.P.2000-04-14
MODIFICATION TO SYNTHES USS (K000450)Synthes Spine2000-03-10
ISOBAR SPINAL SYSTEM (K000425)Encore Orthopedics, Inc.2000-03-07
TRIPLE-FIX SPINAL FIXATION SYSTEM (K992147)Advanced Spine Technology, Inc.2000-02-28
SYNERGY VLS CAP NUT MODELS 2206, 6102 (K000236)Interpore Cross Intl.2000-02-16
MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS) (K991862)Micomed GmbH2000-01-13
OPUS SPINAL SYSTEM (K993402)Howmedica Osteonics Corp.1999-12-20
EBI SPINELINK SYSTEM (K992920)Ebi, L.P.1999-11-23
ISOBAR SPINAL SYSTEM (K992738)Encore Orthopedics, Inc.1999-11-08
ISOBAR SEMI-RIGID SPINAL SYSTEM (K991326)Scien'Tx USA, Inc.1999-11-08
SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22 (K992369)Interpore Cross Intl.1999-10-13
EBI OMEGA 21 SYSTEM (K992333)Electro-Biology, Inc.1999-10-08
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM (K992276)Sulzer Spine-Tech1999-10-01
CD HORIZON SPINAL SYSTEM (K992928)Sofamor Danek USA,Inc.1999-09-21
EBI OMEGA 21 SYSTEM (K991721)Ebi Electro Biology1999-08-13
SYNERGY ADJUSTABLE LENGTH ROD (K990057)Interpore Cross Intl.1999-06-28
MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM (K990745)Synthes Spine1999-03-30
SYNERGY D2 SPINAL IMPLANTS (K984578)Interpore Cross Intl.1999-03-23
OSTEONICS COMBINATION SCREW RING/BLOCKER (K990158)Osteonics Corp.1999-02-01
OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS (K990059)Howmedica Osteonics Corp.1999-01-28
TIMX LOW BACK SYSTEM (K984348)Depuy Motech Acromed1999-01-20
VSP SYSTEM (K984350)Depuy Motech Acromed1999-01-20
SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM (K984612)Synthes Spine1999-01-19
EBI SPINELINK SYSTEM (K984027)Electro-Biology, Inc.1999-01-19
MODIFICATION OF TSRH SPINAL SYSTEM (K984522)Danek Medical, Inc.1999-01-06
DEPUY ACROMED MOSS SPINAL SYSTEM (K984378)Depuy, Inc.1998-12-30
CD SPINAL SYSTEM (K980184)Sofamor Danek USA,Inc.1998-12-18
DYNA-LOK SPINAL SYSTEM (K983672)Sofamor Danek USA,Inc.1998-12-16
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM (K982987)Synthes Spine1998-10-21
TSRH SPINAL SYSTEM (K982990)Sofamor Danek USA,Inc.1998-10-21
MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM (K983260)Spinal Concepts, Inc.1998-10-21
MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM (K983258)Spinal Concepts, Inc.1998-10-21
ISOLA SPINAL SYSTEM (K980485)Acromed Corp.1998-10-21
AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS (K982914)Aesculap, Inc.1998-10-02
AESCULAP SPINE SYSTEM EVOLUTION (K980484)Aesculap, Inc.1998-10-02
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