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KWP

430 FDA 510(k) clearances · Product code

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RecordFirmDate
ALPHA POSTERIOR SPINAL SYSTEM (K964275)Sofamor Danek USA,Inc.1997-01-14
HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM (K962314)Osteonics Corp.1996-12-09
CD HORIZON SPINAL SYSTEM (K961633)Sofamor Danek USA,Inc.1996-12-05
ISOLA PEDIATRIC COMPONENTS (K962984)Acromed Corp.1996-11-27
ACROMED PEDICLE SCREW (K963639)Acromed Corp.1996-11-14
COTREL-DUBOUSSET (CD) SPINAL (K955807)Sofamor Danek USA,Inc.1996-10-01
COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM (K955365)Sofamor Danek USA,Inc.1996-03-27
J.B. S. C1-C2 CLAMP (K955864)J.B.S., S.A.1996-03-15
BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION) (K955927)Arcan Orthopaedic Corp.1996-03-13
ROGOZINSKI THORACOLUMBAR SPINAL ROD (K954696)Smith & Nephew Richards, Inc.1996-03-11
TITANIUM MOSS MIAMI SPINAL SYSTEM (K955348)Depuy, Inc.1996-02-16
MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS (K951846)Alphatec Mfg., Inc.1996-02-14
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) (K955173)Osteotech, Inc.1996-02-09
CD LIBERTY POSTERIOR SPINCAL SYSTEM (K951164)Sofamor Danek USA,Inc.1996-02-09
CENTRA-LINE GRAPPLE, VARIFIX SYSTEM (K954770)Advanced Spine Fixation Systems, Inc.1996-01-25
TITANIUM GDLH POSTERIOR SPINAL SYSTEM (K954645)Sofamor Danek USA,Inc.1996-01-16
CLAMP ASSEMBLY (K953599)J.B.S., S.A.1995-12-19
SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS (K936294)Sofamor Danek Mfg., Inc.1995-12-19
J.B.S. CERVICAL SPINE SYSTEM (K942432)J.B.S., S.A.1995-07-11
WEBB-MORLEY SPINE SYSTEM (K945781)Electro-Biology, Inc.1995-06-22
BRYAN POSTERIOR SPINAL FIXATOR (BPSF) (K945435)Arcan Orthopaedic Corp.1995-05-31
APOFIX CERVICAL SPINE FIXATION (K945022)Sofamor Co.1995-05-15
AME UNIVERSAL FIXATION SYSTEM (K931381)American Medical Electronics, Inc.1995-02-01
J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE (K935113)J.B.S., S.A.1994-10-19
STRYKER 2S SPINAL SYSTEM (K930009)Stryker Corp.1994-09-01
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM (K933881)Depuy, Inc.1994-07-12
ALPHA SPINAL SYSTEM (K930515)Alphatec Mfg., Inc.1994-06-29
D-C-S SYSTEM (K930657)Pina-Vertriebs1994-06-29
GDLH VARIABLE ANGLE CONNECTOR (K934582)Danek Group, Inc.1994-06-21
TI-FRAME (K934860)Johnson & Johnson Professionals, Inc.1994-06-03
SOFAMOR ORFIL SPINE FIXATION SYSTEM (K934007)Sofamor Co.1994-06-02
TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON (K933205)Danek Medical, Inc.1994-05-04
LOW PROFILE MID CROSS BRACING (K931225)Advanced Spine Fixation Systems, Inc.1994-05-02
SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST (K930891)Synthes (Usa)1994-04-29
BRYAN SPINAL FIXATER (BSF) (K914548)Arcan Orthopaedic Corp.1994-03-28
LOW PROFILE SLEAVE NUT ASSEMBLY (K931208)Advanced Spine Fixation Systems, Inc.1994-03-28
AME(R) RIGID FIXATION SYSTEM (K930531)American Medical Electronics, Inc.1994-02-01
SENTRY POSTERIOR SPINAL SYSTEM (K930710)Sofamor Danek Mfg., Inc.1993-10-01
SELBY INSTRUMENTATION (K924474)Advanced Spine Fixation Systems, Inc.1993-09-21
COTREL - DUBOUSSET SPINE IMPLANTS (K921056)Buckman Co., Inc.1993-06-24
COMPACT COTREL -- DUBOUSSET SPINE SYSTEM (K921767)Buckman Co., Inc.1993-06-22
SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST (K921948)Synthes (Usa)1993-06-22
CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT (K924142)Codman & Shurtleff, Inc.1993-06-15
EDWARDS ADJUSTABLE CONNECTORS (K915672)Scientific Spinal , Ltd.1993-05-26
ISOLA(R) TANDEM CONNECTOR (K922504)Acromed Corp.1993-05-18
TSRH CENTRAL POST HOOKS (K925811)Sofamor Danek Mfg., Inc.1993-05-18
AUGMENT POSTERIOR SPINAL FIXATION SYSTEM (K922672)Sofamor Danek Mfg., Inc.1993-05-18
LUQUE V SPINAL SYSTEM (K921256)Sofamor Danek Mfg., Inc.1993-05-18
PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS (K924381)Cross Medical Products, Inc.1993-05-18
PARAGON POSTERIOR SPINAL SYSTEM (K920546)Sofamor Danek Mfg., Inc.1993-01-21
ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR (K921090)Acromed Corp.1992-12-31
ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION (K920392)Acromed Corp.1992-12-31
LEAPLAZA FRAME (K922238)Spintech, Inc.1992-12-23
MODIFIED TSRH CENTRAL POST HOOKS (K922520)Sofamor Danek Mfg., Inc.1992-11-16
TSRH L CONNECTOR -- MODIFICATION (K923339)Sofamor Danek Mfg., Inc.1992-10-27
MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS (K912837)Kirschner Medical Corp.1992-08-26
TSRH(TM) LATERAL OFFSET PLATE (K914306)Sofamor Danek Mfg., Inc.1992-06-19
TSRH CENTRAL POST HOOKS (K914966)Sofamor Danek Mfg., Inc.1992-05-12
THE SELBY SYSTEM (K920102)Advanced Spine Fixation Systems, Inc.1992-05-05
PWB LUMBOSACRAL SPINE SYSTEM (K920116)Cross Medical Products, Inc.1992-04-10
CROSSLINK SYSTEM (K911663)Synthes (Usa)1992-03-23
TSRH VARIABLE ANGLE SACRAL SCREW (K904243)Danek Medical, Inc.1992-01-22
LUQUE SEGMENTAL SPINAL INSTRUMENTATION (K913561)Zimmer, Inc.1992-01-16
EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO (K914269)Scientific Spinal , Ltd.1991-12-18
RAY SACRAL FIXATION SYSTEM (K904520)Danek Medical, Inc.1991-10-25
CROSSLINK PLATE (K911307)Danek Medical, Inc.1991-10-24
DANEK SACRAL HOOK, MODIFICATION (K911379)Danek Medical, Inc.1991-09-11
TSRH OPEN HEAD BONE SCREW (K911319)Danek Medical, Inc.1991-09-06
ISOLA(TM) SPINE SYSTEM - ILIAC SCREW (K911528)Acromed Corp.1991-06-28
ISOLA(TM) SPINE SYSTEM--EYE ROD (K911394)Acromed Corp.1991-06-21
ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTOR (K905826)Acromed Corp.1991-03-21
ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK (K905184)Acromed Corp.1991-02-15
ACROMED SACRAL SCREW (K903376)Acromed Corp.1990-12-27
KNIGHT SACRAL SCREW (K902775)Danek Medical, Inc.1990-12-10
TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS) (K901005)Danek Medical, Inc.1990-12-10
TSRH OFFSET AND SIDE-LOADING HOOKS (K903461)Danek Medical, Inc.1990-12-05
MODULOCK POSTERIOR SPINAL FIXATION (K902397)Zimmer, Inc.1990-11-05
TSRH SACRAL L-CONNECTOR (K901587)Danek Medical, Inc.1990-11-05
DANEK SACRAL HOOK (K901590)Danek Medical, Inc.1990-08-21
CHIBA SPINAL SYSTEM (K895978)Danek Medical, Inc.1990-08-09
ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS (K896106)Richards Medical Co., Inc.1990-06-25
DANEK PRECISION ROD SET (K896254)Danek Medical, Inc.1990-06-14
SELBY II INSTRUMENTATION (K895296)Advanced Spine Fixation1990-03-20
AXIAL AND OFFSET CROSSLINK PLATES (K896740)Danek Medical, Inc.1990-02-26
HSC UNIT ROD (K896603)Danek Medical, Inc.1990-01-30
LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET (K890192)Danek Medical, Inc.1990-01-04
ACROMED BUTTON SPINAL WIRE (K895441)Acromed Corp.1989-11-22
ACROMED DOUBLE SUBLAMINAR WIRE (K895413)Acromed Corp.1989-11-22
ACROMED BEADED SUBLAMINAR WIRE (K895439)Acromed Corp.1989-11-22
STUART CD UNIVERSAL ROD CONNECTOR CLAMPS (K894702)Bio-Medical Prosthetics1989-10-11
CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL (K894472)Buckman Co., Inc.1989-10-10
SELBY INSTRUMENTATION (K884998)Advanced Spine Fixation Systems, Inc.1989-06-22
KIRSCHNER SPINAL FIXATOR KMS-1 (K884690)Kirschner Medical Corp.1989-06-02
ACROMED ILIAC SCREW (K884161)Buckman Co., Inc.1989-05-03
ACROMED SPINAL ROD AND SPINAL HOOKS (K884163)Buckman Co., Inc.1989-04-26
THE C-S DISTRACTION ROD ASSEMBLY (K890187)Orthopedic Systems, Inc.1989-04-06
TSRH SACRAL SPINAL SCREW (K883783)Warsaw Orthopedic, Inc.1989-04-06
MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD (K884688)Synthes (Usa)1989-02-24
LEA PLAZA SPINAL FRAME SYSTEM (K884585)Orthomet, Inc.1989-01-27
ROGOZINSKI SPINAL SYSTEM (K884263)Richards Medical Co., Inc.1988-12-29
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