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Orthopedic

17,044 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS (K001046)Biopro, Inc.2000-06-08
OMEGA II MODULAR TOTAL HIP SYSTEM (K000817)Osteoimplant Technology, Inc.2000-06-08
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS (K001548)Howmedica Osteonics Corp.2000-06-07
WINDOW CERVICAL DYNAMIC PLATE SYSTEM (K993066)Advanced Spine Technology, Inc.2000-06-07
BOFOR REVISION COUP (K993874)Plus Orthopedics2000-06-05
TRIFIX SPINAL FIXATION SYSTEM (K001627)Endius, Inc.2000-06-03
TRI-FIX SPINAL FIXATION SYSTEM (K000766)Endius, Inc.2000-06-01
REACH FEMORAL COMPONENT (K000760)Biomet, Inc.2000-05-23
PASS SPINAL SYSTEM (K001024)Encore Orthopedics, Inc.2000-05-23
XIA SPINE SYSTEM HOOKS (K001319)Howmedica Osteonics Corp.2000-05-23
HOFFMANN II EXTERNAL FIXATION SYSTEM (K000957)Howmedica Osteonics Corp.2000-05-23
NEER III TOTAL SHOULDER SYSTEM (K994350)Smith & Nephew, Inc.2000-05-23
EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM (K001358)Ebi, L.P.2000-05-23
CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ (K001307)Implex Corp.2000-05-23
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED (K001335)Exactech, Inc.2000-05-18
MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS (K001451)DePuy Orthopaedics, Inc.2000-05-18
METAL ON METAL ACETABULAR SYSTEM (K993438)Biomet, Inc.2000-05-18
LATERAL PIVOT INSERT (K000590)Encore Orthopedics, Inc.2000-05-11
ERS RADIAL HEAD REPLACEMENT (K000658)DePuy Orthopaedics, Inc.2000-05-11
XIA SPINE SYSTEM (K001272)Howmedica Osteonics Corp.2000-05-11
PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) (K000694)Pectofix, Inc.2000-05-11
STRYKER TRAUMA PLATING SYSTEM (K000636)Howmedica Osteonics Corp.2000-05-11
MULTI-AXIAL CROSS (MAC) CONNECTOR (K000965)Howmedica Osteonics Corp.2000-05-11
COLORADO II SPINAL SYSTEM (K991031)Sofamor Danek USA,Inc.2000-05-10
KEYSTONE HIP (K000521)Encore Orthopedics, Inc.2000-05-10
PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601 (K000734)Pioneer Surgical Technology2000-05-05
VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS (K000691)Oratec Interventions, Inc.2000-05-04
MODULAR-PLUS REVISION STEM (K994126)Plus Orthopedics2000-05-04
SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM (K000682)Synthes (Usa)2000-05-01
BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B (K000506)Arthrex, Inc.2000-05-01
SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM (K000684)Synthes (Usa)2000-04-28
ASCENT KNEE REVISION FEMORAL STEM (K001010)Biomet, Inc.2000-04-27
BIOLOK SCREW (K993630)Encore Orthopedics, Inc.2000-04-26
DELTALOC ANTERIOR CERVICAL PLATE SYSTEM (K993513)Alphatec Mfg., Inc.2000-04-26
RESPONSE 2000 CEMENTED HIP STEM (K000432)DePuy Orthopaedics, Inc.2000-04-24
MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS (K001105)Depuyacromed2000-04-24
RESPONSE 2000 HIP STEM (K000392)DePuy Orthopaedics, Inc.2000-04-24
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
HAIDER-UCR SPINAL SYSTEM (K993503)International Advanced Medical Enterprises, Inc.2000-04-14
MODIFICATION TO EBI SPINELINK SYSTEM (K001037)Ebi, L.P.2000-04-14
ABC CERVICAL PLATING SYSTEM (K000486)Aesculap, Inc.2000-04-14
SYNTHES (USA) WRIST FUSION PLATES (WFP) (K000558)Synthes (Usa)2000-04-14
MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS (K990830)Biomet, Inc.2000-04-11
CORTEK ARTHROSCOPE (K000198)Cortek Endoscopy, Inc.2000-04-11
5.0MM SPINAL SCREWS (K994288)Ortho Tec, LLC2000-04-10
HEMISPHERE MODULAR CUP SYSTEM (K000321)Ortho Development Corp.2000-04-10
ESKA MODULAR HIP SYSTEM (K993027)Specs USA, Inc.2000-04-06
OSTEONICS SERIES 7000 AD TIBIAL TRAY (K983657)Osteonics Corp.2000-04-06
BICON-PLUS ACETABULAR COMPONENTS (K992154)Plus Orthopedics2000-04-06
PEDIATRIC FIXATION RODS (K000764)Biomet, Inc.2000-04-06
PROVEN KNEE SYSTEM (K000113)Stelkast Company2000-04-04
BOHN FEMORAL COMPONENT (K000262)Biomet Manufacturing, Inc.2000-04-03
ASNIS III CANNULATED SCREW SYSTEM (K000080)Howmedica Osteonics Corp.2000-04-03
OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 (K000797)Orthopaedic Biosystems, Ltd.2000-04-03
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) (K000046)Richard Wolf Medical Instruments Corp.2000-03-30
COLORADO II SPINAL SYSTEM (K984360)Sofamor Danek USA,Inc.2000-03-30
SINGLE SIZE TENDON SPACER (K000019)Medist International2000-03-29
SYNTHES ANTERIOR CSLP SYSTEM (K000742)Synthes Spine2000-03-29
ORTHO DEVELOPMENT BALANCED KNEE SYSTEM (K994370)Ortho Development Corp.2000-03-24
SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 (K000616)Bionx Implants, Ltd.2000-03-23
PINNACLE ACETABULAR SYSTEM (K000306)DePuy Orthopaedics, Inc.2000-03-23
TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM (K994366)Howmedica Osteonics Corp.2000-03-16
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL (K000538)Biomet, Inc.2000-03-15
SYNTHES ANTERIOR CSLP SYSTEM (K000536)Synthes Spine2000-03-15
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM (K000066)Synthes (Usa)2000-03-15
CENTAUR SPINAL SYSTEM (K994347)Howmedica Osteonics Corp.2000-03-15
SYNTHES BUTTON PLATE (K994364)Synthes (Usa)2000-03-15
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE (K994207)Howmedica Osteonics Corp.2000-03-13
DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT (K000091)Howmedica Osteonics Corp.2000-03-10
SPIRAL RADIUS RODDING SYSTEM (K000009)United States Surgical, A Division of Tyco Healthc2000-03-10
NONLINEAR TAPER LAG SCREW (K994382)Theken Surgical2000-03-10
AEQUALIS SHOULDER FRACTURE SYSTEM (K994392)Tornier2000-03-10
MODIFICATION TO SYNTHES USS (K000450)Synthes Spine2000-03-10
MODIFICATION TO CD SPINAL SYSTEM (K000476)Medtronic Sofamor Danek, Inc.2000-03-10
MAGELLAN TIBIAL INTRAMEDULLARY NAIL (K992850)Orthomatrix, Inc.2000-03-10
INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS (K993259)Sulzer Orthopedics, Inc.2000-03-10
MAGELLAN HUMERAL INTRAMEDULLARY NAIL (K992856)Orthomatrix, Inc.2000-03-10
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD (K000575)DePuy Orthopaedics, Inc.2000-03-10
MODIFICATION TO CD SPINAL SYSTEM (K000453)Medtronic Sofamor Danek, Inc.2000-03-10
ZMR HIP SYSTEM-POROUS REVISION (K994286)Zimmer, Inc.2000-03-10
ROD TO ROD CROSS BRACES (K000634)Corin USA2000-03-10
MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM (K000513)Ebi, L.P.2000-03-07
ISOBAR SPINAL SYSTEM (K000425)Encore Orthopedics, Inc.2000-03-07
INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS) (K994363)Richard Wolf Medical Instruments Corp.2000-03-06
THE LIGAMENT ANCHOR SOFT SCREW (K994152)Corin USA2000-03-06
SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM (K994128)Howmedica Osteonics Corp.2000-03-06
STAPLETAC2 BONE ANCHOR SYSTEM (K000279)American Medical Systems, Inc.2000-03-01
PHALANGEAL FIXATION SYSTEM (K994232)Medcanica, Inc.2000-03-01
CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ (K990330)Implex Corp.2000-03-01
BLACKSTONE SPINAL FIXATION SYSTEM (K994217)Blackstone Medical, Inc.2000-02-28
TRIPLE-FIX SPINAL FIXATION SYSTEM (K992147)Advanced Spine Technology, Inc.2000-02-28
ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS (K000232)Corin USA2000-02-25
CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS (K994153)Corin USA2000-02-25
EBI XFIX DFS SYSTEM (K000319)Ebi, L.P.2000-02-25
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM (K994202)Smith & Nephew, Inc.2000-02-25
MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM (K000335)Biomet, Inc.2000-02-25
RADIAL HEAD PROSTHESIS (K992220)Smith & Nephew, Inc.2000-02-25
MEMOGRAPH STAPLE, WARM SYSTEM (K993714)Biomedical Ent., Inc.2000-02-25
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES] (K994143)Smith & Nephew, Inc.2000-02-18
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