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Orthopedic

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

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RecordFirmDate
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM (K050471)Solco Biomedical Co., Ltd.2005-05-12
ARTHREX TAK FAMILY (K050749)Arthrex, Inc.2005-05-12
ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM (K051083)Acumed, LLC2005-05-12
TRABECULAR METAL ACETABULAR REVISION SHELLS (K050937)Zimmer Trabecular2005-05-11
RADIOPAQUE BONE CEMENT (K043518)Cardinalhealth2005-05-11
ALUMINA HEAD (K050556)Fournitures Hospitalieres Industrie2005-05-11
HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM (K050892)Blackstone Medical, Inc.2005-05-11
HA COATED LAG SCREW (K050849)Smith & Nephew, Inc.2005-05-04
BASIS SPINAL SYSTEM (K050484)Medtronic Sofamor Danek, Inc.2005-05-04
ABC 2 SCREW (K050813)Aesculap, Inc.2005-05-04
PROCOTYL-E ACETABULAR SYSTEM (K043073)Wrightmedicaltechnologyinc2005-05-04
LAGUNA PEDICLE SCREW SYSTEM (K050060)Allez Spine, LLC2005-05-04
KNEE FUSION NAIL (K050938)Smith & Nephew, Inc.2005-05-04
MODIFICATION TO MBCP (K043005)Biomatlante2005-05-03
RX90 LOW PROFILE ACETABULAR SYSTEM (K042989)Biomet, Inc.2005-04-28
SYNTHES (USA) 3.5MM CONICAL SCREWS (K050683)Synthes (Usa)2005-04-27
DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM (K050932)Hand Innovations, Inc.2005-04-26
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES (K050646)Synthes (Usa)2005-04-26
SBI HAND FIXATION SYSTEM (TM) (K050462)Small Bone Innovations, LLC2005-04-26
SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS (K050636)Synthes (Usa)2005-04-21
CAMCERAM TCP (K050357)Cam Implants B.V.2005-04-21
VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM (K050588)Innovative Spinal Design, LLC2005-04-21
SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS (K050580)Smith & Nephew Endoscopy, Inc.2005-04-20
MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS (K050723)Zimmer, Inc.2005-04-20
ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL (K043083)Wrightmedicaltechnologyinc2005-04-18
WAGNER SL REVISION STEM LATERAL (K043356)Zimmer Austin, Inc.2005-04-18
NOVEL VBR SPINAL SYSTEM (K050553)Alphatec/Nexmed2005-04-18
REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG (K043339)Xtremi-T, LLC2005-04-18
THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 (K050101)Zimmer Trabecular2005-04-15
ARTHERX CORKSCREW FT II SUTURE ANCHOR (K050358)Arthrex, Inc.2005-04-15
LANX ANTERIOR CERVICAL PLATE SYSTEM (K050774)Lanx, LLC2005-04-11
OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER (K050490)Medicrea2005-04-11
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K043053)Medtronic Sofamor Danek2005-04-11
STRYKER SPINE AVS PL PEEK SPACER (K050624)Stryker Spine2005-04-11
ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM (K050761)Zimmer, Inc.2005-04-11
ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER (K042565)Ortho Development Corp.2005-04-11
EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE (K050675)Depuy Spine, Inc.2005-04-11
MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM (K050804)Aesculap, Inc.2005-04-11
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO) (K050607)Synthes (Usa)2005-04-11
CHARLOTTE SNAP-OFF SCREW (K050819)Wrightmedicaltechnologyinc2005-04-11
SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION (K050631)Synthes (Usa)2005-04-11
GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES (K050666)Berkeley Advanced Biomaterials, Inc.2005-04-11
OSSAPLAST ORTHO (K050416)Ossacur AG2005-03-29
SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT (K050539)Howmedica Osteonics Corp.2005-03-29
MAESTRO CARPAL HEMIARTHROPLASTY (K050028)Biomet Manufacturing, Inc.2005-03-25
BIOLOX DELTA CERAMIC HEADS (K042091)Biomet, Inc.2005-03-25
BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET (K050497)Linvatec Corp.2005-03-25
DYNAGRAFT II (K040419)Isotis Orthobiologics, Inc.2005-03-25
CD HORIZON SPINAL SYSTEM (K050439)Medtronic Sofamor Danek, Inc.2005-03-24
SYNTHES VECTRA SYSTEM (K050451)Synthes Spine Co.Lp2005-03-24
ENCORE REVERSE SHOULDER PROSTHESIS (K041066)Encore Medical L.P.2005-03-24
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K043488)Medtronic Sofamor Danek2005-03-21
STRYKER LOCKED PLATING SYSTEM (K050512)Howmedica Osteonics Corp.2005-03-21
MODIFICATION TO: ARTHREX V-TAK (K050634)Arthrex, Inc.2005-03-21
MODIFICATION TO: RESTORATION MODULAR SYSTEM (K050138)Howmedica Osteonics Corp.2005-03-21
DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX (K040262)Musculoskeletal Transplant Foundation2005-03-17
STABILIZATION SCREW (K050346)New Deal, S.A.2005-03-17
AEQUALIS REVERSED SHOULDER PROSTHESIS (K050316)Tornier2005-03-16
SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS (K042899)Synthes (Usa)2005-03-16
EXCIA TOTAL HIP SYSTEM (K042344)Aesculap, Inc.2005-03-16
MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM (K050457)Merete Medical GmbH2005-03-14
SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE (K042515)Smith & Nephew, Inc.2005-03-14
UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD (K043570)Conformis, Inc.2005-03-14
PINNACLE CONSTRAINED ACETABULAR LINERS (K043058)Depuy, Inc.2005-03-14
TAMARACK ANTERIOR THORACOLUNBAR (K050390)Alphatec/Nexmed2005-03-14
AOS HUMERAL NAIL (K050241)Advanced Orthopaedic Solutions, Inc.2005-03-14
INTEGRA BONE FIXATION SYSTEM (K050492)Integra Lifesciences Corp.2005-03-14
SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT (K041825)Smith & Nephew, Inc.2005-03-11
MODIFICATION TO DYNESYS SPINAL SYSTEM (K043565)Zimmer Spine, Inc.2005-03-11
SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (K043526)Noble Fiber Technologies, Inc.2005-03-10
ARCOMXL POLYETHYLENE LINERS (K042051)Biomet, Inc.2005-03-08
MODIFICATION TO: INION OTPS BIODEGRADABLE PIN (K050275)Inion , Ltd.2005-03-07
NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS (K043101)Zimmer, Inc.2005-03-07
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM (K043578)Solco Biomedical Co., Ltd.2005-03-07
SYNTHES (USA) LCP MODULAR FOOT PLATES (K050110)Synthes (Usa)2005-03-04
HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM (K050048)Howmedica Osteonics Corp.2005-03-04
STRYKER SPINE TRIO PS (K043180)Stryker Spine2005-03-02
THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER (K050227)Linvatec Corp.2005-03-02
SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM (K050041)Synthes (Usa)2005-02-25
EPIPHYSIS SCREW (K043410)I.T.S. Implantat-Technologie-Systeme GmbH2005-02-24
SMITH & NEPHEW, INC. REVISION KNEE SYSTEM (K043440)Smith & Nephew, Inc.2005-02-18
MODIFICATION TO TSRH SPINAL SYSTEM (K050282)Medtronic Sofamor Danek2005-02-18
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM (K043142)Inion , Ltd.2005-02-18
BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B (K043145)Arthrex, Inc.2005-02-18
BLAKSTONE LAMINOPLASTY FIXATION SYSTEM (K043338)Blackstone Medical, Inc.2005-02-18
ROC LUMBAR PLATING SYSTEM (K050078)Alphatec/Nexmed2005-02-18
STANSION MATRIX (K042600)Spineworks, LLC2005-02-18
INTERGRO DBM (K031399)Interpore Cross Intl.2005-02-18
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM (K050117)Medtronic Sofamor Danek2005-02-17
BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS (K043100)Biomet, Inc.2005-02-17
RESOFIX BIOABSORBABLE EXPANSION BOLT (K043411)Resofix, Inc.2005-02-17
MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM (K042928)U&I Corp.2005-02-17
DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING (K043374)Howmedica Osteonics Corp.2005-02-16
OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC (K043421)Regeneration Technologies, Inc.2005-02-16
GAMMA3 NAIL SYSTEM (K043431)Howmedica Osteonics Corp.2005-02-16
EBI TROCHANTERIC NAIL SYSTEM (K050118)Ebi, L.P.2005-02-16
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL (K043308)Depuy Spine, Inc.2005-02-16
TECHTONIX SYSTEM (K050189)Stryker Spine2005-02-16
TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS (K043248)Arthrex, Inc.2005-02-16
VANGUARD SSK KNEE SYSTEM (K042757)Biomet, Inc.2005-02-11
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