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Orthopedic

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

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RecordFirmDate
SC TOTAL HIP SYSTEM (K031474)Orthopedic Alliance, LLC2003-10-15
BIO-INTRAFIX TIBIAL SCREW AND SHEATH (K032167)Mitek Worldwide2003-10-15
GENESIS II POROUS PLUS HA KNEE SYSTEM (K032683)Smith & Nephew, Inc.2003-10-15
PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT (K031901)Stelkast Company2003-10-10
ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01 (K031471)Ortho Tec, LLC2003-10-10
KLS-MARTIN STERNAL PLATING SYSTEM (K032413)KLS-Martin L.P.2003-10-10
SHIRAZ-JAVA SPINAL FIXATION SYSTEM (K031265)Spine Next SA2003-10-09
FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM (K032427)Meridan Medical2003-10-09
GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT (K032581)Howmedica Osteonics Corp.2003-10-09
ACCOLADE-J HIP STEM SERIES (K032300)Howmedica Osteonics Corp.2003-10-09
BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS (K032700)Blackstone Medical, Inc.2003-10-09
SONOMA ANTERIOR CERVICAL PLATE SYSTEM (K032368)Seaspine2003-10-09
NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS (K031061)Zimmer, Inc.2003-10-09
T2 RECON NAIL SYSTEM (K032898)Howmedica Osteonics Corp.2003-10-09
ENDOTINE FOREHEAD DEVICE (K032770)Coapt Systems, Inc.2003-10-08
ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B (K032098)Arthrex, Inc.2003-10-07
NORMED COMPRESSION BONE SCREW SYSTEM (K032634)Noviace Corporation2003-10-06
ACE NANCY NAIL (K032687)DePuy Orthopaedics, Inc.2003-10-06
EPSILON DURASUL CONSTRAINED ACETABULAR LINER (K030923)Centerpulse Orthopedics, Inc.2003-10-03
HLS NOETOS SYSTEM (K032079)Tornier2003-10-02
LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE (K032072)Arthrotek, Inc.2003-10-01
DISTAL RADIUS FRACTURE REPAIR SYSTEM (K032705)Hand Innovations, Inc.2003-10-01
TRIGEN STRAIGHT HUMERAL NAIL SYSTEM (K032722)Smith & Nephew, Inc.2003-10-01
DEPUY 1 GENTAMICIN BONE CEMENT (K023103)DePuy Orthopaedics, Inc.2003-09-29
IRRIGATION SETS (K032832)Vital Concepts, Inc.2003-09-26
DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS (K032151)Depuy, Inc.2003-09-26
GLOBAL CAP RESURFACING REPLACEMENT SHOULDER (K031971)DePuy Orthopaedics, Inc.2003-09-24
PALACOS R (K030902)Heraeus Kulzer GmbH & Co. KG2003-09-23
OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS (K032606)Exactech, Inc.2003-09-23
OSTEOPAL (K030903)Heraeus Kulzer GmbH & Co. KG2003-09-23
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM (K031214)Encore Medical L.P.2003-09-23
PALAMED (K030904)Heraeus Medical GmbH Technology2003-09-23
MODULAR PLUS HIP STEM (K032709)Plus Orthopedics2003-09-23
MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION (K031449)Implex Corp.2003-09-23
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM (K032187)Arthrex, Inc.2003-09-22
ULTRA-DRIVE 3 (K031280)Biomet, Inc.2003-09-22
ARTHREX TRIMIT SCREW, MODEL AR-4161B (K031945)Arthrex, Inc.2003-09-22
HALM ZIELKE INSTRUMENTATION SYSTEM (K024125)Micomed Ortho GmbH2003-09-22
MODIFICATION TO HIGHGATE CURVED ROD SYSTEM (K023983)Highgate Orthopaedics2003-09-22
PROCLASS PRESS FIT HIP STEM (K032110)Stelkast Company2003-09-22
ESKA MODULAR HIP SYSTEM CEMENTED (K030867)Eska Implants GmbH2003-09-22
WAGNER CONE PROSTHESIS (K032380)Centerpulse Orthopedics, Inc.2003-09-22
CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) (K032169)Cyberorthology, Inc.2003-09-22
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES (K032269)Synthes (Usa)2003-09-17
TSRH SPINAL SYSTEM (K032578)Medtronic Sofamor Danek, Inc.2003-09-17
SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM (K031855)Spinal Concepts, Inc.2003-09-17
TSRH SPINAL SYSTEM (K031967)Medtronic Sofamor Danek, Inc.2003-09-17
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 (K032529)Hydrocision, Inc.2003-09-16
ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00, (K031972)Asap Endoscopic Products GmbH2003-09-15
KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A (K032212)Kyphon, Inc.2003-09-15
DURACON TOTAL KNEE SYSTEM (K032163)Howmedica Osteonics Corp.2003-09-12
CD HORIZON SPINAL SYSTEM (K032033)Medtronic Sofamor Danek2003-09-12
MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) (K032588)Disco-O-Tech Medical Technologies, Ltd.2003-09-12
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING (K032418)Howmedica Osteonics Corp.2003-09-11
SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM (K031985)Spinal Concepts, Inc.2003-09-11
IP-XS COMPRESSION NAIL SYSTEM (K032548)Plus Orthopedics2003-09-10
TI FENESTRATED PLATE (K031772)Interpore Cross Intl.2003-09-05
INTERLOK BIO-MODULAR HUMERAL STEMS (K032507)Biomet, Inc.2003-09-05
SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE (K031973)Synthes (Usa)2003-09-05
ALANTECH GRAFT FIXATION SCREW (K031937)Arthrocare Corp.2003-09-04
SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES (K032032)Synthes (Usa)2003-09-04
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) (K032037)Medtronic Sofamor Danek2003-09-04
EBI XFIX DFS SYSTEM (K031919)Ebi, L.P.2003-09-04
HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS (K032479)Howmedica Osteonics Corp.2003-09-04
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K031833)Medtronic Sofamor Danek2003-09-03
TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM (K031729)Howmedica Osteonics Corp.2003-09-02
KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT (K030237)Kapp Surgical Instrument, Inc.2003-08-29
36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS (K031730)Howmedica Osteonics Corp.2003-08-29
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER (K032409)Orthovita, Inc.2003-08-29
S2 NAIL SYSTEM (K032579)Howmedica Osteonics Corp.2003-08-29
MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM (K024313)Pisharodi Surgicals, Inc.2003-08-29
INION OTPS BIODEGRADABLE PIN (K031712)Inion , Ltd.2003-08-28
MITEK MICRO QUICKANCHOR (K032078)Mitek Worldwide2003-08-25
OSTEOMED SUBTALAR IMPLANT SYSTEM (K031155)Osteomed LP2003-08-22
COLUMBUS (PS) (K030367)Aesculap, Inc.2003-08-21
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT (K032295)Smith & Nephew, Inc.2003-08-21
SYNTHES (USA) CALVICLE HOOK PLATE (K031677)Synthes (Usa)2003-08-21
RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS (K032396)Biomet, Inc.2003-08-21
MODIFICATION ORIA SPINAL SYSTEM (K023884)Ortho Tec, LLC2003-08-20
MODIFICATION TO CERASORB ORTHO (K031651)Curasan AG2003-08-13
EVOLVE CERAMIC RADIAL HEAD IMPLANT (K030384)Wrightmedicaltechnologyinc2003-08-12
ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL (K032367)Zimmer, Inc.2003-08-12
MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS (K030055)Biomet, Inc.2003-08-11
LORENZ 2.4 SELF DRILLING SCREWS (K032228)Walter Lorenz Surgical, Inc.2003-08-11
CD HORIZON SPINAL SYSTEM (K032265)Medtronic Sofamor Danek2003-08-11
GAMMA 3 NAIL SYSTEM (K032244)Howmedica Osteonics Corp.2003-08-08
REFLEX ANTERIOR CERVICAL PLATE SYSTEM (K031702)Howmedica Osteonics2003-08-08
MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM (K032264)Howmedica Osteonics Corp.2003-08-08
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212 (K032197)Smith & Nephew, Inc.2003-08-08
OPUS SPINAL SYSTEM (K030369)Howmedica Osteonics Corp.2003-08-08
HBS HEADLESS BONE SCREW (K030302)Schoening & Assoc., Inc.2003-08-08
OMNIFIT HFX HIP STEM SERIES (K031744)Howmedica Osteonics Corp.2003-08-08
SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE (K031428)Synthes (Usa)2003-08-08
BIORCI SCREW (K032224)Smith & Nephew, Inc.2003-08-08
VKS/TC-PLUS REVISION KNEE (K032215)Plus Orthopedics2003-08-08
DEPUY ACE VERSANAIL TIBIAL NAIL (K032097)DePuy Orthopaedics, Inc.2003-08-08
SPINAL CONCEPTS, INC. INFIX SYSTEM (K031672)Spinal Concepts, Inc.2003-08-07
MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA (K031693)Biomet, Inc.2003-08-06
THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS (K031462)Implex Corp.2003-08-06
EBI OMEGA21 SPINAL FIXATION SYSTEM (K031354)Ebi, L.P.2003-08-06
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