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Orthopedic

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

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RecordFirmDate
MALIBU SPINAL SYSTEM (K051942)Seaspine, Inc.2005-07-27
MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ (K051756)Zimmer Trabecular2005-07-27
S4 SPINAL SYSTEM (K050979)Aesculap, Inc.2005-07-27
TRABECULAR METAL REVISION SHELL LINERS (K051516)Zimmer, Inc.2005-07-27
ALEUTIAN SPACER SYSTEM (K051454)K2m, LLC2005-07-27
XIA 4.5 SPINAL SYSTEM (K050461)Stryker Spine2005-07-27
OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES (K050681)TriMed, Inc.2005-07-27
PLC SCREW (K051310)Smith & Nephew, Inc.2005-07-26
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (K051180)Vanguard Medical Concepts, Inc.2005-07-22
CD HORIZON SPINAL SYSTEM (K051674)Medtronic Sofamor Danek USA, Inc.2005-07-21
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM (K050391)Globus Medical, Inc.2005-07-21
OSCAR, MODEL OE3000DB (K051053)Orthosonics, Ltd.2005-07-21
ACUMED RIB CONGRIENT BONE PLATE SYSTEM (K051410)Acumed, LLC2005-07-21
PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT (K051229)Smith & Nephew, Inc.2005-07-20
MODIFICATION TO SHOULDER FIXATION SYSTEM (K051728)Hand Innovations, LLC2005-07-20
MARROW PLUS (M+) (K051695)Berkeley Advanced Biomaterials, Inc.2005-07-19
EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM (K051682)Exactech, Inc.2005-07-19
PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY (K051735)Smith & Nephew, Inc.2005-07-19
DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES (K050210)Biomet, Inc.2005-07-19
HYDRALOK SYSTEM (K051216)Altiva Corp.2005-07-19
MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE (K051737)Howmedica Osteonics Corp.2005-07-19
SECUR-FIT MAX AND PLUS MAX HIP STEMS (K051738)Howmedica Osteonics Corp.2005-07-19
GENEROS SB SMALL BONE DISTRACTION IMPLANT (K051162)Orthonetx, Inc.2005-07-19
ANATOMICAL SHOULDER KEELED GLENOID (K051623)Zimmer GmbH2005-07-19
VERTEBROPLASTIC RADIOPAQUE BONE CEMENT (K043406)Depuy Spine, Inc.2005-07-15
TORNIER ELBOW PROSTHESIS (K050848)Tornier2005-07-14
SEMIAL SPINAL IMPLANT (K051659)Signus Medizintechnik GmbH2005-07-13
SYNTHES (USA) LOW-PROFILE WRIST FIXATOR (K051049)Synthes (Usa)2005-07-13
T-PLATE ANTERIOR FIXATION SYSTEM (K051764)Esm Technologies2005-07-13
TRIATHLON KNEE SYSTEM (K051146)Howmedica Osteonics Corp.2005-07-13
BIOLOX DELTA CERAMIC FEMORAL HEADS (K051588)Howmedica Osteonics Corp.2005-07-12
MALIBU SPINAL SYSTEM (K051663)Seaspine, Inc.2005-07-12
HUMERAL HEAD PLATE WITH ANGULAR STABILITY (K051412)I.T.S. Implantat-Technologie-Systeme GmbH2005-07-11
ROI FUSION RODS & PLATES (K051309)Reiley Orthopaedics, Inc.2005-07-11
SOLCO 4CIS GENERAL PLATE SYSTEM (K051155)Solco Biomedical Co., Ltd.2005-07-11
PIVOT BIPOLAR FEMORAL HEAD (K050966)Ortho Development Corp.2005-07-07
CONNEXUS (K050690)Isotis Orthobiologics, Inc.2005-07-07
PALACOS LV+G (K050854)Heraeus Kulzer,GmbH2005-07-07
MERETE TWISTCUT SNAP-OFF BONE SCREW (K051323)Merete Medical GmbH2005-07-07
QUANTUM VERTEBRAL BODY REPLACEMENT (K050449)Quantum Orthopedics, Inc.2005-07-07
T2 RECON NAIL SYSTEM (K051624)Howmedica Osteonics Corp.2005-07-07
PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES (K051098)Zimmer, Inc.2005-07-07
PALAMED G (K050855)Heraeus Kulzer,GmbH2005-07-07
EXPEDIUM SPINE SYSTEM (K051024)Depuy Spine, Inc.2005-07-06
TRABECULAR METAL PRIMARY HIP PROSTHESIS (K051491)Zimmer, Inc.2005-06-30
TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS (K051557)Smith & Nephew, Inc.2005-06-30
MC+ PARTIAL VBR (K043479)Ldr Spine USA2005-06-30
INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS (K051408)Intelifuse, Inc.2005-06-29
STALIF TT (K051027)Surgicraft , Ltd.2005-06-29
OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) (K043349)Ldr Spine USA2005-06-29
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES (K051554)Alliance Medical Corp.2005-06-29
PUSHLOCK (K051219)Arthrex, Inc.2005-06-29
R-X-FIX EXTERNAL FIXATOR (K051017)R-X-Fix2005-06-29
ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS (K051411)Biomet, Inc.2005-06-29
NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER (K051069)Arthrotek, Inc.2005-06-29
TAPER 2 POROUS FEMORAL STEM (K050441)Biomet, Inc.2005-06-29
SYNTHACER; SYNTRICER (K041177)Medartis Medizinprodukte Und Forschung AG2005-06-23
RESTORATION MODULAR SYSTEM (K051363)Howmedica Osteonics Corp.2005-06-23
CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM (K050852)I.T.S. Implantat-Technologie-Systeme GmbH2005-06-22
ZODIAC SPINAL FIXATION SYSTEM (K050830)Alphatec/Nexmed2005-06-22
ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS (K051335)Exactech, Inc.2005-06-21
ZODIAC SPINAL FIXATION SYSTEM (K051286)Alphatec/Nexmed2005-06-17
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM (K051306)Howmedica Osteonics Corp.2005-06-17
PARALLAX ACRYLIC RESIN WITH TRACERS TA (K050864)Arthrocare Corp.2005-06-17
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 (K051196)Implex Corp.2005-06-17
ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM (K043176)Arc Surgical, LLC2005-06-17
SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM (K051326)Smith & Nephew, Inc.2005-06-15
TRANS1 AXIALIF SYSTEM (K050965)Trans1 Incorporated2005-06-14
CONSTRUX MINI PEEK VBR SYSTEM (K051246)Blackstone Medical, Inc.2005-06-14
BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM (K043548)Blackstone Medical, Inc.2005-06-14
CD HORIZON SPINAL SYSTEM (K050809)Medtronic Sofamor Danek USA, Inc.2005-06-14
MENDEC SPINE (K042415)Tecres S.P.A.2005-06-09
AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR (K051250)Axya Medical, Inc.2005-06-09
BASIS VERTEBRAL BODY SPACER (K051105)Medtronic Sofamor Danek2005-06-09
STERLING INTERFERENCE SCREW ST (K050767)Regeneration Technologies, Inc.2005-06-09
CENTERPIECE PLATE FIXATION SYSTEM (K050082)Medtronic Sofamor Danek, Inc.2005-06-06
CALLOS IMPACT AND INJECT BONE VOID FILLER (K051123)Skeletal Kinetics, LLC2005-06-03
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT (K051086)Smith & Nephew, Inc.2005-05-31
NEWDEAL ANKLE NAIL (K050882)New Deal, S.A.2005-05-27
MAXLOCK (K050868)Orthohelix Surgical Designs, Inc.2005-05-27
CO VERTEBRAL BODY REPLACEMENT (K050348)Scient'X2005-05-27
MERETE DUOTHREADTM BONE SCREW (K050924)Merete Medical GmbH2005-05-27
ARTHREX BIO-PIN (K050259)Arthrex, Inc.2005-05-27
BALANCE HIP SYSTEM (K050251)Biomet, Inc.2005-05-27
ENCORE REVERSE SHOULDER PROSTHESIS (K051075)Encore Medical L.P.2005-05-27
FORMAGRAFT COLLAGEN BONE GRAFT MATRIX (K050789)R and D Medical, LLC2005-05-27
PEEK CAS (K050861)Interpore Cross Intl.2005-05-27
XPAND CORPECTOMY SPACER (K050850)Globus Medical, Inc.2005-05-26
CUSTOM-HIP TOOL (K051181)Orthopedic Sciences, Inc.2005-05-23
POLYAXIAL HEMISPHERICAL SPINAL SCREWS (K051063)Scient'X2005-05-23
TITANIUM-HIP TOOL (K051032)Orthopedic Sciences, Inc.2005-05-23
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE (K051000)Spinal Concepts, Inc.2005-05-19
BIOPRO TARA FEMORAL RESURFACING COMPONENT (K043542)Biopro, Inc.2005-05-18
PRECIMED CANNULATED SCREW SYSTEM (K050754)Precimed, Inc.2005-05-18
NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS (K050105)Zimmer, Inc.2005-05-17
THEKEN REVEAL VBR SYSTEM (K050058)Theken Surgical,Llc2005-05-17
CD HORIZON SPINAL SYSTEM (K050981)Medtronic Sofamor Danek USA, Inc.2005-05-17
LANX SPINAL FIXATION SYSTEM (K043484)Lanx, LLC2005-05-16
DELTA HUMERAL CUPS (K050315)DePuy Orthopaedics, Inc.2005-05-16
BASIS SPINAL SYSTEM (K051039)Medtronic Sofamor Danek USA, Inc.2005-05-12
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