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MNH

309 FDA 510(k) clearances · Product code

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RecordFirmDate
ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM (K071890)Alphatec Spine, Inc.2007-11-09
MODIFICATION TO PASSMED SPINAL SYSTEM (K070530)Medicrea Technologies2007-10-18
CAPLESS LI PEDICLE SCREW SYSTEM (K072282)X-Spine Systems, Inc.2007-09-14
LOWTOP PEDICLE SCREW SYSTEM (K070933)Sanacor2007-06-13
VERTIFLEX SPINAL SCREW SYSTEM (K062670)Vertiflex (Tm), Incorporated2007-01-12
MODIFICATION TO EXPEDIUM SPINE SYSTEM (K062174)Depuy Spine, Inc.2006-11-02
ISS INTEGRATED SPINE SYSTEM (K061524)Ortho Development Corp.2006-09-26
MANTIS SPINAL SYSTEM (K061813)Stryker Spine2006-09-19
OVALTWIST PEDICLE SCREW SYSTEM (K061577)Signus Medizintechnik GmbH2006-09-14
SFX SNAP-FIT CROSS CONNECTOR (K062196)Depuy Spine, Inc.2006-09-11
PILOT POSTERIOR LUMBAR PLATING SYSTEM (K061364)Life Spine2006-09-05
MODIFICATION TO NUVASIVE SPHERX II SYSTEM (K062317)Nuvasive, Inc.2006-09-01
BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 (K061162)Applied Spine Technologies, Inc.2006-07-26
EBI 5.5 HELICAL FLANGE SPINAL SYSTEM (K061441)Ebi, L.P.2006-07-25
CD HORIZON SPINAL SYSTEM (K061915)Medtronic Sofamor Danek2006-07-25
NUVASIVE SPHERX II SYSTEM (K061778)Nuvasive, Inc.2006-07-18
NFIX FUSION SYSTEM (K053623)N-Spine, Inc.2006-07-12
ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX (K061321)Alphatec Spine, Inc.2006-07-07
4CIS VANE SPINE SYSTEM (K060702)Solco Biomedical Co., Ltd.2006-06-22
SSP PEDICLE SCREW SYSTEM (K060118)Specialty Spine Products, LLC2006-06-08
NUVASIVE SPHERX SYSTEM (K060225)Nuvasive, Inc.2006-04-12
GSS PEDICLE SCREW SYSTEM (K053573)GS Medical Co., Ltd.2006-03-08
CONTOUR II SPINAL SYSTEM (K053070)Altiva Corp.2006-02-13
GII SPINAL FIXATION SYSTEM (K051089)Co-Ligne AG2005-10-26
NV CORMED SOLAS SPINAL SYSTEM (K051959)Nv Cormed2005-10-12
ARCTEC SEMIRIGID PLATING SYSTEM (K051044)Altiva Corp.2005-10-07
SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM (K051697)Medical Device Advisory Development Group2005-09-21
XIA 4.5 SPINAL SYSTEM (K050461)Stryker Spine2005-07-27
HYDRALOK SYSTEM (K051216)Altiva Corp.2005-07-19
ZODIAC SPINAL FIXATION SYSTEM (K051286)Alphatec/Nexmed2005-06-17
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM (K050471)Solco Biomedical Co., Ltd.2005-05-12
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM (K043578)Solco Biomedical Co., Ltd.2005-03-07
STRYKER SPINE TRIO PS (K043180)Stryker Spine2005-03-02
ROC LUMBAR PLATING SYSTEM (K050078)Alphatec/Nexmed2005-02-18
MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM (K042928)U&I Corp.2005-02-17
VERTEBRON PSS PEDICLE SCREW SYSTEM (K043152)Vertebron, Inc.2005-02-01
MODIFICATION TO: CD HORIZON SPINAL SYSTEM (K043343)Medtronic Sofamor Danek2004-12-28
MX POLYAXIAL PEDICLE SCREW (K043001)Scient'X2004-12-01
UNI-THREAD SPINAL SYSTEM (K042640)Spine Vision, Inc.2004-11-23
MX MONOAXIAL PEDICLE SCREW (K042964)Scient'X2004-11-22
ALADYN RIGID SPINE PLATE (K040747)Scient'X2004-06-17
PROCYON SPINAL SYSTEM (K033512)Nas Medical Technologies, Inc.2004-06-03
PROTEX STABILIZATION SYSTEM (K040442)Globus Medical, Inc.2004-05-20
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K034056)Medtronic Sofamor Danek2004-04-21
NUVASIVE SPINAL SYSTEM (K033546)Nuvasive, Inc.2004-04-12
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K040072)Medtronic Sofamor Danek, Inc.2004-02-12
GII SPINAL FIXATION SYSTEM (K032604)Co-Ligne AG2004-01-20
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K033322)Medtronic Sofamor Danek2003-12-15
STRYKER SPINE MAPS SYSTEM (K032855)Howmedica Osteonics2003-12-10
SHIRAZ-JAVA SPINAL FIXATION SYSTEM (K031265)Spine Next SA2003-10-09
EBI P148 SPINAL FIXATION SYSTEM (K031423)Ebi, L.P.2003-06-27
U&I, OPTIMA, SPINAL SYSTEM (K031585)U&I Corp., America2003-06-27
ORIA CLARIS (K023378)Ortho Tec, LLC2003-06-27
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) (K030581)Blackstone Medical, Inc.2003-06-26
MODIFICATION TO EASYS TRANSVERSE CONNECTION (K031290)Scient'X USA, Inc.2003-05-13
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS (K030383)Depuyacromed2003-02-26
ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ (K023994)Ortho Tec, LLC2003-02-05
MONARCH SPINE SYSTEM (K024348)Depuyacromed2003-01-28
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X (K020085)Sintea Biotech, Inc.2002-12-10
MODIFICATION TO MONARCH SPINE SYSTEM (K023438)Depuyacromed2002-11-13
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM (K023204)Ebi, L.P.2002-10-18
UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS (K021623)Iame, Inc.2002-09-10
ENDIUS TITLE SPINAL FIXATION SYSTEM (K021881)Endius, Inc.2002-07-29
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM (K020356)Alphatec Mfg., Inc.2002-07-23
COLORADO 2 SPINAL SYSTEM (K020247)Medtronic Sofamor Danek, Inc.2002-07-22
MONARCH SPINE SYSTEM (K021335)Depuyacromed2002-07-11
CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) (K021879)Depuyacromed2002-06-26
CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM) (K021880)Depuyacromed2002-06-26
EQUATION FIXATION SYSTEM (K013962)Medtronic Sofamor Danek, Inc.2002-06-20
TSRH SPINAL SYSTEM (K020699)Medtronic Sofamor Danek, Inc.2002-05-28
MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD (K021148)Depuyacromed2002-05-08
EBI OMEGA21 SPINAL FIXATION SYSTEM (K020681)Ebi, L.P.2002-04-03
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW (K020674)Blackstone Medical, Inc.2002-04-03
UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM (K014302)Pisharodi Surgicals, Inc.2002-03-29
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM (K020196)Sulzer Spine-Tech2002-02-15
OSTEONICS SPINAL SYSTEM (K020293)Howmedica Osteonics Corp.2002-02-14
BACFIX SPINAL FIXATION SYSTEM (K013887)Spinal Concepts, Inc.2002-02-12
MODIFICATION TO ISOBAR SPINAL SYSTEM (K020245)Scien'Tx USA, Inc.2002-02-01
MODIFICATION TO OPUS SPINAL SYSTEM (K014229)Howmedica Osteonics Corp.2002-01-25
MODIFICATION TO EBI OMEGA 21 SYSTEM (K014137)Ebi, L.P.2002-01-16
MODIFICATION TO TSRH SPINAL SYSTEM (K014076)Medtronic Sofamor Danek, Inc.2001-12-27
MODIFICATION TO XIA SPINAL SYSTEM (K013688)Howmedica Osteonics Corp.2001-12-05
ISOBAR SPINAL SYSTEM (K013444)Scien'Tx USA, Inc.2001-11-16
MONARCH SPINAL SYSTEMS (K013294)Depuyacromed2001-10-09
MOSS MIAMI SPINAL SYSTEMS (K013296)Depuyacromed2001-10-09
TIMX SPINAL SYSTEMS (K013295)Depuyacromed2001-10-09
ISOLA SPINAL SYSTEMS (K012971)Depuyacromed2001-10-05
SPIRAL RADIUS 90-D SST SYSTEM (K012273)United States Surgical, A Division of Tyco Healthc2001-08-15
MODIFICATION TO XIA SPINE SYSTEM (K012027)Howmedica Osteonics2001-07-20
SCS CLOSED SCREW (K003733)Ortho Tec, LLC2001-05-29
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS (K011182)Depuyacromed2001-05-16
CLARIS PLATE SYSTEM (K010369)Ortho Tec, LLC2001-05-08
MODIFICATION TO OSTEONICS SPINAL SYSTEM (K010845)Howmedica Osteonics Corp.2001-04-18
MOSS MIAMI 5.5MM TITANIUM PIN NUT (K010742)Depuyacromed2001-04-12
TSRH SPINAL SYSTEM (K010720)Medtronic Sofamor Danek, Inc.2001-04-11
SOCON SPINAL SYSTEM (K003463)Aesculap, Inc.2001-04-11
TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS (K010776)Corin USA2001-04-06
TRIFIX SPINAL FIXATION SYSTEM (K010535)Endius, Inc.2001-03-19
CD HORIZON SPINAL SYSTEM (K010249)Medtronic Sofamor Danek, Inc.2001-02-23
MODIFICATION TO EBI SPINELINK SYSTEM (K003764)Ebi, L.P.2001-01-02
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