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Orthopedic

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

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RecordFirmDate
GRAFTCAGE TLX (K051781)Osteotech, Inc.2005-12-16
GRAFTON DBM (K051195)Osteotech, Inc.2005-12-16
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM (K052990)Biomet, Inc.2005-12-16
MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM (K052799)Bonutti Research, Inc.2005-12-16
NEXA BONE SCREW SYSTEM (K053394)Nexa Orthopedics, Inc.2005-12-14
TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD (K052776)Arthrex, Inc.2005-12-13
ARTHREX TENSIONLOK (K052901)Arthrex, Inc.2005-12-12
ORTHOFIX TITANIUM NAILING SYSTEMS (K053261)Orthofix Srl2005-12-12
NUVASIVE COROENT EXTENSURE SYSTEM (K052210)Nuvasive, Inc.2005-12-12
CAPLESS PEDICLE SCREW SYSTEM (K052847)X-Spine Systems, Inc.2005-12-12
HOFFMANN II ROD TO WIRE COUPLING (K053349)Howmedica Osteonics Corp.2005-12-09
COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES (K053189)Zimmer, Inc.2005-12-09
LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM (K051275)Allez Spine, LLC2005-12-09
SYNTHES PANGEA MONOAXIAL SYSTEM (K052151)Synthes Spine Co.Lp2005-12-07
SMITH & NEPHEW MODULAR HIP (K052426)Smith & Nephew, Inc.2005-12-07
KALIX II IMPLANT, MODEL 141 0XX WITH XX (K053093)New Deal, S.A.2005-12-07
SMITH & NEPHEW PLATFORM HIP STEM (K052275)Smith & Nephew, Inc.2005-12-07
DISTAL RADIO-ULNAR JOINT IMPLANT (K053119)Aptis Medical, LLC2005-12-07
MESA SPINAL SYSTEM (K052398)K2m, LLC2005-12-07
POROUS TITANIUM ACETABULAR AUGMENTS (K052888)Biomet Manufacturing Corp2005-12-06
XIA SPINAL SYSTEM (K053115)Stryker Spine2005-12-06
SYNTHES (USA) STERNAL FIXATION SYSTEM (K052683)Synthes (Usa)2005-12-05
VIAGRAF DBM PASTE (K043209)Osteotech, Inc.2005-12-05
ORTHOBLAST II PUTTY AND PASTE (K050642)Isotis Orthobiologics, Inc.2005-12-05
ANSPACH KNOTLESS ANCHOR (K052572)The Anspach Effort, Inc.2005-12-05
LINEAGE A-CLASS POLY LINER (K052026)Wrightmedicaltechnologyinc2005-12-05
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP (K053105)Synthes (Usa)2005-12-02
SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS (K052748)Howmedica Osteonics Corp.2005-12-02
ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM (K051858)Exactech, Inc.2005-12-01
GRAFTCAGE ACX (K053080)Osteotech, Inc.2005-12-01
OPTIUM DBM GEL AND PUTTY (K053098)Lifenet2005-11-28
INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM (K051821)Inion , Ltd.2005-11-25
GRAFTON PLUS DBM PASTE (K043048)Osteotech, Inc.2005-11-23
ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS (K052255)Biomet, Inc.2005-11-23
DEPUY CMW 1 GENTAMICIN BONE CEMENT (K053002)DePuy Orthopaedics, Inc.2005-11-22
NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS (K052879)Zimmer, Inc.2005-11-22
DEPUY CMW 1, 2 AND 3 BONE CEMENTS (K053003)DePuy Orthopaedics, Inc.2005-11-22
VILEX X-FIX (K052196)Vilex, Inc.2005-11-22
HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM (K053038)Howmedica Osteonics Corp.2005-11-22
TRICOS T (K051722)Baxter Healthcare Corp2005-11-18
EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS (K050398)Exactech, Inc.2005-11-18
BETACONE HIP PROSTHESIS SYSTEM (K051826)Waldemar Link GmbH & Co. KG2005-11-18
STRYKER SPINE TRIO SPINAL FIXATION SYSTEM (K052971)Stryker Spine2005-11-16
INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE (K052624)Inion , Ltd.2005-11-16
STERLING INTERFERENC SCREW HT (K052405)Regeneration Technologies, Inc.2005-11-16
THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM (K052950)Zimmer Trabecular2005-11-16
MODIFICATION TO VERTE-STACK SPINAL SYSTEM (K052931)Medtronic Sofamor Danek2005-11-16
PACP SYSTEM (K053053)Pioneer Surgical Technology2005-11-16
TOPEZ TOTAL ANKLE REPLACEMENT (K051023)Topez Orthopedics, Inc.2005-11-15
MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 (K052596)Biopro, Inc.2005-11-15
RBK PATELLA FEMORAL KNEE (K050473)Global Orthopaedic Technology, USA, Inc.2005-11-14
EXTERNAL FIXATION (K052605)Gexfix USA, Inc.2005-11-10
STELLA CERVICAL PLATE (K052763)Scient'X2005-11-10
SOLANAS POSTERIOR STABILIZATION SYSTEM (K052201)Alphatec Spine, Inc.2005-11-10
VERTEFIX VERTEBROPLASTY PROCEDURE SET (K042691)Cook, Inc.2005-11-08
UNI-THREAD SPINAL SYSTEM (K052406)Spine Vision, Inc.2005-11-07
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS (K052607)Arthrex, Inc.2005-11-07
IGNITE BONE VOID FILLER KIT (K052913)Wrightmedicaltechnologyinc2005-11-07
SBI AUTOFIX (K052576)Small Bone Innovations, LLC2005-11-07
STRYKER SPINE AVS ASL PEEK SPACER (K051205)Stryker Spine2005-11-04
LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60 (K050407)Sciences For Bio Materials2005-11-04
SYNTHES (USA) SPHERICAL WASHERS (K052483)Synthes (Usa)2005-11-04
GENEROS 80, GENEROS 60 (K051914)Berkeley Advanced Biomaterials, Inc.2005-11-03
NOVABONE-BIOACTIVE SYNTHETIC GRAFT (K052494)Novabone Products, LLC2005-11-03
ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT (K052736)Arthrex, Inc.2005-11-03
KIMBA SPINAL IMPLANT (K052533)Signus Medizintechnik GmbH2005-11-03
ASCENSION MUH (K052137)Ascension Orthopedics, Inc.2005-11-03
MODIFICATION TO:CD HORIZON SPINAL SYSTEM (K052747)Medtronic Sofamor Danek2005-10-28
WRIST FUSION PLATE (K052754)Dvo Extremity Solutions, LLC2005-10-27
ORTHOPEDIC SALVAGE SYSTEM- OSS (K052685)Biomet, Inc.2005-10-27
V40 BIOLOX DELTA CERAMIC FEMORAL HEADS (K052718)Howmedica Osteonics Corp.2005-10-27
GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM (K051721)Global Orthopaedic Technology, USA, Inc.2005-10-26
GII SPINAL FIXATION SYSTEM (K051089)Co-Ligne AG2005-10-26
OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM (K051656)Osteobiologics, Inc.2005-10-25
COLLAGEN BONE HEALING PROTECTIVE SHEET (K052041)Collagen Matrix, Inc.2005-10-25
SHOULDER NAIL PLATE (K052294)Hand Innovations, LLC2005-10-21
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K052609)Medtronic Sofamor Danek2005-10-21
SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) (K052631)Depuy Mitek, A Johnson & Johnson Company2005-10-21
AVON PATELLO-FEMORAL JOINT PROSTHESIS (K051948)Howmedica Osteonics Corp.2005-10-21
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM (K052734)Medtronic Sofamor Danek2005-10-21
CONCORDE VBR SPINAL SYSTEM (K052746)Depuy Spine, Inc.2005-10-21
SPIDER CERVICAL PLATING (SCP) SYSTEM (K052292)X-Spine Systems, Inc.2005-10-21
PINNACLE CONSTRAINED ACETABULAR LINERS (K052079)DePuy Orthopaedics, Inc.2005-10-21
OLECRANONPLATE WITH ANGULAR STABILITY (K052368)I.T.S. Implantat-Technologie-Systeme GmbH2005-10-17
ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) (K052630)Depuy Mitek, A Johnson & Johnson Company2005-10-17
PROVEN REVISION MODULAR TIBIAL TRAY (K051976)Stelkast Company2005-10-17
TECTONIC CERVICAL PLATE SYSTEM (K051531)K2m, LLC2005-10-17
FRAGMENT SPECIFIC FIXATOR (K052498)David J. Slutsky MD2005-10-17
MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM (K051815)Vertebron, Inc.2005-10-17
HYBRID ANTERIOR CERVICAL PLATE SYSTEM (K052552)Depuy Spine, Inc.2005-10-13
SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP) (K052677)Synthes (Usa)2005-10-12
SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS (K051977)Howmedica Osteonics Corp.2005-10-12
NV CORMED SOLAS SPINAL SYSTEM (K051959)Nv Cormed2005-10-12
UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS (K050373)Arthrosurface, Inc.2005-10-11
MODIFICATION TO: XIA 4.5 SPINAL SYSTEM (K052761)Stryker Spine2005-10-11
ANTHOLOGY HIP STEM (K052792)Smith & Nephew, Inc.2005-10-07
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM (K052261)Medtronic Sofamor Danek USA, Inc.2005-10-07
EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE (K050997)Flexuspine, Inc.2005-10-07
SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION (K052390)Synthes (Usa)2005-10-07
EQUATOR PLUS ACETABULAR CUP SYSTEM (K051844)Portland Orthopaedics Pty. , Ltd.2005-10-07
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