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KWP

430 FDA 510(k) clearances · Product code

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RecordFirmDate
BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM (K080394)Blackstone Medical, Inc.2008-03-13
BLACKSTONE ASCENT MULTIAXIAL SCREWS (K073420)Blackstone Medical, Inc.2008-02-14
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR (K073654)Blackstone Medical, Inc.2008-01-24
ISSYS LP SPINAL FIXATION SYSTEM (K072866)Custom Spine, Inc.2007-12-13
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K071942)Medtronic Sofamor Danek2007-12-11
ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM (K072081)Alphatec Spine, Inc.2007-10-24
TRAVERSE OCT SPINAL FIXATION SYSTEM (K062447)Medtronic Sofamor Danek, Inc.2007-10-15
MODIFICATION TO OASYS SYSTEM (K072568)Stryker Spine2007-10-05
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K070742)Medtronic Sofamor Danek2007-09-14
LANX DEFORMITY SYSTEM (K071633)Lanx, LLC2007-08-15
LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM (K070341)Ldr Spine USA2007-08-08
POLARIS BE RODS (K071377)Biomet Spine2007-08-06
GSO GS1 SPINAL SYSTEM (K070966)Gold Standard Orthopaedics, LLC2007-07-20
THEKEN ATOLL CERVICO-THORACIC SYSTEM (K070638)Theken Spine, LLC2007-05-30
ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM (K061943)Anatomica AB2007-05-25
EXPEDIUM SFX CROSS CONNECTOR SYSTEM (K070300)Depuy Spine, Inc.2007-04-10
C-JAWS CERVICAL COMPRESSIVE MINI FRAME (K062181)Medicrea Technologies2007-01-16
LTD POLYAXIAL FIXATION SYSTEM (K062785)Us Spine2006-12-26
APEX SPINE SYSTEM (K062513)Spinecraft, Inc.2006-12-22
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K061591)Medtronic Sofamor Danek, Inc.2006-09-08
SYNTHES OC FUSION SYSTEM (K053418)Synthes Spine Co.Lp2006-09-06
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K061579)Medtronic Sofamor Danek2006-08-11
DENALI DEFORMITY SYSTEM (K052404)K2m, LLC2006-05-23
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM (K060683)Endius, Inc.2006-04-18
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X (K060513)Sintea Biotech, Inc.2006-03-10
BASIS SPINAL SYSTEM (K060081)Medtronic Sofamor Danek2006-02-13
SOLANAS POSTERIOR STABILIZATION SYSTEM (K052201)Alphatec Spine, Inc.2005-11-10
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM (K052734)Medtronic Sofamor Danek2005-10-21
EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS (K052131)Depuy Spine, Inc.2005-09-28
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM (K052376)Medtronic Sofamor Danek2005-09-23
SYNTHES PANGEA SYSTEM (K052123)Synthes (Usa)2005-09-23
VERTEX RECONSTRUCTION SYSTEM (K052402)Medtronic Sofamor Danek2005-09-23
NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX (K052247)Abbott Spine, Inc.2005-09-14
MODIFICATION TO XIA SPINAL SYSTEM (K052181)Stryker Spine2005-09-08
VERTEBRON PSS PEDICLE SCREW SYSTEM (K051716)Vertebron, Inc.2005-09-07
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K052180)Medtronic Sofamor Danek2005-08-23
MODIFICATION TO: XIA STAINLESS STEEL SYSTEM (K051973)Stryker Spine2005-08-18
PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES (K052069)Globus Medical, Inc.2005-08-17
MALIBU SPINAL SYSTEM (K051942)Seaspine, Inc.2005-07-27
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM (K050391)Globus Medical, Inc.2005-07-21
ZODIAC SPINAL FIXATION SYSTEM (K050830)Alphatec/Nexmed2005-06-22
CD HORIZON SPINAL SYSTEM (K050809)Medtronic Sofamor Danek USA, Inc.2005-06-14
BASIS SPINAL SYSTEM (K050484)Medtronic Sofamor Danek, Inc.2005-05-04
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K043053)Medtronic Sofamor Danek2005-04-11
TECHTONIX SYSTEM (K050189)Stryker Spine2005-02-16
CD HORIZON SPINAL SYSTEM (K050079)Medtronic Sofamor Danek USA, Inc.2005-02-10
ISSYS PEDICLE SCREW SYSTEM (K043522)Custom Spine, Inc.2005-01-14
MODIFICATION TO XIA SPINAL SYSTEM (K043473)Stryker Spine2005-01-12
DENALI SPINE SYSTEM (K042635)K2m, LLC2005-01-10
GLAXY 3.2 SPINAL SYSTEM (K043020)Medtronic Sofamor Danek2005-01-07
VERTEX RECONSTRUCTION SYSTEM (K042789)Medtronic Sofamor Danek2004-12-21
MODIFICATION TO ALTIUS OCT SYSTEM (K043229)Interpore Cross Intl.2004-12-21
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X (K043355)Sintea Biotech, Inc.2004-12-17
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K042673)Alphatec/Nexmed2004-10-27
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K042524)Medtronic Sofamor Danek2004-10-08
VERTEX RECONSTRUCTION SYSTEM (K042498)Medtronic Sofamor Danek2004-10-07
EXCELLA-M SPINAL SYSTEM (K042143)Innovasis, Inc.2004-10-07
SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM (K042508)Depuy Spine, Inc.2004-10-07
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K042402)Medtronic Sofamor Danek, Inc.2004-10-01
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM (K041808)Endius, Inc.2004-10-01
ST360 SPINAL FIXATION SYSTEM (K041925)Zimmer Spine, Inc.2004-09-24
CORAL SPINAL SYSTEM (K041592)Theken Surgical2004-09-16
CD HORIZON SPINAL SYSTEM (K041862)Medtronic Sofamor Danek2004-09-15
EXPEDIUM SPINE SYSTEM (K041119)Depuy Spine, Inc.2004-07-19
SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT (K041449)Interpore Cross Intl.2004-07-01
SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM (K040096)Spinal Concepts, Inc.2004-07-01
MODIFICATION TO TSRH SPINAL SYSTEM (K041282)Medtronic Sofamor Danek, Inc.2004-06-10
ALTIUS OCT SYSTEM (K033961)Interpore Cross Intl.2004-04-14
ICON POLYAXIAL PEDICLE SCREW SYSTEM (K033090)Alphatec Mfg., Inc.2004-03-26
BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION) (K033980)Blackstone Medical, Inc.2004-03-03
PASSMED SPINAL SYSTEM (K032094)Medicrea2003-11-14
CLICK'X MONOAXIAL SCREWS AND HOOKS (K031175)Synthes (Usa)2003-11-14
ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01 (K031471)Ortho Tec, LLC2003-10-10
TI FENESTRATED PLATE (K031772)Interpore Cross Intl.2003-09-05
MODIFICATION ORIA SPINAL SYSTEM (K023884)Ortho Tec, LLC2003-08-20
XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM (K031893)Howmedica Osteonics Corp.2003-07-17
U & I AMERICA SPINAL HOOK SYSTEM (K031595)U&I Corp., America2003-06-24
MODIFICATION TO COLORADO 2 SPINAL SYSTEM (K030875)Medtronic Sofamor Danek, Inc.2003-06-24
ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 (K031452)Ortho Tec, LLC2003-06-18
VANTAGE ANTERIOR FIXATION SYSTEM (K031533)Medtronic Sofamor Danek, Inc.2003-06-13
BLACKSTONE POSTERIOR CERVICAL SYSTEM (K030197)Blackstone Medical, Inc.2003-06-12
MSD CABLE REDUCTION SYSTEM (K030816)Medtronic Sofamor Danek2003-06-06
MODIFICATION TO XIA STAINLESS STEEL SYSTEM (K031090)Howmedica Osteonics Corp.2003-04-24
ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 (K030253)Ortho Tec, LLC2003-02-21
ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07) (K030252)Ortho Tec, LLC2003-02-21
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM (K030241)Blackstone Medical, Inc.2003-02-21
MOSS MIAMI SPINAL SYSTEM PIN NUT (K023804)Depuyacromed2003-01-23
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM (K023797)Medtronic Sofamor Danek2002-12-13
MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM (K023415)Medtronic Sofamor Danek2002-12-13
CD HORIZON SPINAL SYSTEM (K014296)Medtronic Sofamor Danek2002-12-10
INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM (K022048)Interpore Cross Intl.2002-12-04
SYNTHES CERVIFIX/ AXON (K023675)Synthes (Usa)2002-11-26
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K023555)Medtronic Sofamor Danek, Inc.2002-11-22
ORIA SPINAL CLIP SYSTEM (K021679)Ortho Tec, LLC2002-11-19
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM (K023498)Blackstone Medical, Inc.2002-11-13
CADENCE SPINAL FIXATION SYSTEM (K022374)Sulzer Spine-Tech2002-09-24
MODIFICATION TO TENOR SPINAL SYSTEM (K022191)Medtronic Sofamor Danek, Inc.2002-08-28
5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM) (K022623)Depuyacromed2002-08-27
PLUS PIVOT LINK UNIVERSAL SYSTEM (K021507)Spine Vision, Inc.2002-08-01
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K021061)Medtronic Sofamor Danek2002-07-25
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