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Orthopedic

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

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RecordFirmDate
SYNTHES CERVIFIX SYSTEM (K011969)Synthes (Usa)2001-07-19
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER (K011455)Biomet, Inc.2001-07-18
SURGICAL DYNAMICS MESH CAGE SYSTEM (K003709)United States Surgical, A Division of Tyco Healthc2001-07-18
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM (K010681)Depuyacromed2001-07-18
TRIDENT ALL POLY CUP (K012026)Howmedica Osteonics Corp.2001-07-18
1.5MM BONE FIXATION KIT (K012000)Bionx Implants, Ltd.2001-07-18
SMARTSCREW (K012001)Bionx Implants, Ltd.2001-07-18
LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW (K011076)Walter Lorenz Surgical, Inc.2001-07-16
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION) (K011976)Exactech, Inc.2001-07-16
METAL TRANSCEND ARTICULATION SYSTEM (K004043)Wrightmedicaltechnologyinc2001-07-13
POLY-TAPES WITH THE FASTLOK FIXATION DEVICE (K010051)Xiros Plc2001-07-13
HOFFMAN II HYBRID RING CLAMP (K011948)Howmedica Osteonics Corp.2001-07-13
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS (K011942)Tornier2001-07-13
IN-FAST BONE SCREW SYSTEM (K011910)American Medical Systems, Inc.2001-07-13
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT (K003954)Biocomposites, Ltd.2001-07-12
SIGN IM NAIL (K011129)Sign, Inc.2001-07-11
SCS DT-02 TRANSVERSE CONNECTOR (K003823)Ortho Tec, LLC2001-07-11
OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT (K011138)Biomet, Inc.2001-07-10
GLOBAL FX POROUS-COATED HUMERAL STEM (K011099)DePuy Orthopaedics, Inc.2001-07-06
AUTO-DRIVE LAG SCREW SYSTEM (K010964)Osteomed Corp.2001-07-05
SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE (K011170)Synthes (Usa)2001-07-05
PLUS CANCELLOUS BONE SCREWS (K011719)Plus Orthopedics2001-07-02
M2A ACETABULAR SYSTEM (K011110)Biomet, Inc.2001-07-02
MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM (K011711)Ebi, L.P.2001-06-29
GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT (K011047)DePuy Orthopaedics, Inc.2001-06-28
SCORPIO CR SUPERFLEX TIBIAL INSERT (K011643)Howmedica Osteonics Corp.2001-06-28
ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND (K011083)Arthrocare Corp.2001-06-28
SYNTHES STERNAL FIXATION SYSTEM (K010943)Synthes (Usa)2001-06-27
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM (K011034)Synthes (Usa)2001-06-27
ORTHOGENESIS LPS SYSTEM (K003182)Depuy, Inc.2001-06-27
EBI XFIX ACCESS PELVIC FIXATOR (K011697)Ebi, L.P.2001-06-27
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR (K011299)Smith & Nephew, Inc.2001-06-27
TITANIUM COMPRESSION ANCHOR SYSTEM (K010884)Anchor Medical Technologies2001-06-20
PFC SIGMA LUGGED TIBIAL TRAY (K003026)DePuy Orthopaedics, Inc.2001-06-19
TORNIER TOTAL ELBOW PROSTHESIS (K011567)Tornier2001-06-19
RESORBABLE HAMMERTOE PIN (K011137)Biomet, Inc.2001-06-19
K'FIX (K010847)Avanta Orthopaedics, Inc.2001-06-19
KSEA MINIATURE TELESCOPE AND ACCESSORIES (K010987)KARL STORZ Endoscopy-America, Inc.2001-06-19
FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM (K010988)Disc-O-Tech Medical Technologies, Ltd.2001-06-19
RADIAL HEAD IMPLANT (K011819)Avanta Orthopaedics, Inc.2001-06-19
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B (K010901)Disc-O-Tech Medical Technologies, Ltd.2001-06-19
ARTHREX BIO-TRANSFIX (K011172)Arthrex, Inc.2001-06-19
OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS (K011622)Howmedica Osteonics Corp.2001-06-15
EXETER HIP SYSTEM WITH V40 TAPER (K011623)Howmedica Osteonics Corp.2001-06-15
EXCEL FRACTURE CEMENTED HIP STEM (K011367)DePuy Orthopaedics, Inc.2001-06-15
MODIFICATION TO THE BOLD SCREW (K011262)New Deal, S.A.2001-06-15
MEMODYN STAPLE (K002695)Telos Medical Equipment2001-06-13
PLLA PIN (K010983)Bionx Implants, Inc.2001-06-13
WORLAND UNICONDYLAR TIBIAL BEARING (K011795)Biomet, Inc.2001-06-13
BARRETT UNICONDYLAR TIBIAL BEARING (K011509)Biomet, Inc.2001-06-13
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE (K010766)Synthes (Usa)2001-06-12
CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION (K010181)Medtronic Sofamor Danek, Inc.2001-06-12
CD HORIZON SPINAL SYSTEM (K011508)Medtronic Sofamor Danek, Inc.2001-06-12
ISOLA BAND CLAMP (K010972)Depuyacromed2001-06-12
TROCHANTERIC NAIL (K010780)DePuy Orthopaedics, Inc.2001-06-12
T2 HUMERAL NAIL SYSTEM (K011529)Howmedica Osteonics Corp.2001-06-12
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 (K011007)Arthrex, Inc.2001-06-12
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
TBW (K010545)Tri-Med, Inc.2001-06-06
BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM (K011390)Disc-O-Tech Medical Technologies, Ltd.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
BUTTERFLY PLATE FUNCTION SYSTEM (K010632)Medtronic Sofamor Danek USA, Inc.2001-05-31
CONVERGENCE CERVICAL SPINAL SYSTEM (K010639)Spinal Innovations, LLC2001-05-30
SYNTHES RESORABLE MESHES AND SHEETS (K003788)Synthes (Usa)2001-05-30
PERC-D SPINEWAND (K010811)Arthrocare Corp.2001-05-30
2.0/2.4 CANNULATED SCREW SYSTEM (K010783)Osteomed Corp.2001-05-30
SCAPHIX, STAPLE, FIXATION, BONE (K003033)Avanta Orthopaedics, Inc.2001-05-30
SCS CLOSED SCREW (K003733)Ortho Tec, LLC2001-05-29
DJ ORTHOPEDICS POST SCREW (K010594)Dj Orthopedics, LLC2001-05-29
SYNTHES SYNEX SPACER SYSTEM (K003836)Synthes2001-05-29
MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A (K010554)Bionx Implants, Inc.2001-05-25
JAX GRANULES BONE VOID FILLER (K010557)Smith & Nephew, Inc.2001-05-25
END-TO-END AND SIDE-BY-SIDE CONNECTORS (K010563)Spinal Concepts, Inc.2001-05-25
TC-PLUS POROUS FEMORAL COMPONENTS (K011258)Plus Orthopedics2001-05-24
TC-PLUS POROUS TIBIAL COMPONENTS (K011288)Plus Orthopedics2001-05-24
WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 (K003618)Whiteside Biomechanics, Inc.2001-05-23
LACTOSORB PLATES, MESHES, AND PANELS/SHEETS (K011237)Biomet, Inc.2001-05-23
MONARCH SPINE SYSTEM (K010576)Depuyacromed2001-05-23
SYNTHES ANTEROLATERAL CALCANEAL PLATE (K010518)Synthes (Usa)2001-05-23
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM (K010525)Arthrex, Inc.2001-05-23
ASCENT KNEE SYSTEM (K011219)Biomet, Inc.2001-05-18
EBI DYNAFIX VS OSTEOTOMY SYSTEM (K010551)Ebi, L.P.2001-05-17
GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM (K010101)Kinamed, Inc.2001-05-17
TETHER ACFS (K010466)Theken Surgical,Llc2001-05-16
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1 (K011218)Exactech, Inc.2001-05-16
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS (K011182)Depuyacromed2001-05-16
ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924 (K010457)Arthrex, Inc.2001-05-14
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS (K003504)Plus Orthopedics2001-05-11
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM (K010633)Mitek Products2001-05-09
SURGICAL TITANIUM MESH SYSTEM (K003043)Depuyacromed2001-05-08
CLARIS PLATE SYSTEM (K010369)Ortho Tec, LLC2001-05-08
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM (K002824)Aesculap, Inc.2001-05-08
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR (K003735)Blackstone Medical, Inc.2001-05-08
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR (K010479)Bonutti Research, Inc.2001-05-08
DJ ORTHOPEDICS INTERFERENCE SCREW (K010595)Dj Orthopedics, LLC2001-05-08
XPS 3000 SYSTEM (K010677)Medtronic Xomed, Inc.2001-05-07
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