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Orthopedic

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

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RecordFirmDate
SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP) (K020244)Synthes Spine2002-04-22
TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM (K020963)Biomet Orthopedics, Inc.2002-04-16
SYNTHES VERTEBRAL SPACER TI (K020152)Synthes (Usa)2002-04-16
NBX - NON-BRIDGING EXTERNAL FIXATOR (K020905)Biomet Orthopedics, Inc.2002-04-15
SYNTHES DUAL-OPENING USS (K020517)Synthes (Usa)2002-04-15
ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM (K020145)Orthopaedic Innovations, Inc.2002-04-15
CONSENSUS ACETABLAR SHELL, TI COATED (K020153)Hayes Medical, Inc.2002-04-15
SPIRAL RADIUS 90-D RODDING SYSTEM (K020134)United States Surgical, A Division of Tyco Healthc2002-04-15
AVON PATELLAR COMPONENT (K020841)Howmedica Osteonics Corp.2002-04-11
ENVISION ANTERIOR CERVICAL PLATE SYSTEM (K020649)Ortho Development Corp.2002-04-05
MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS) (K020970)Biomet, Inc.2002-04-04
LONG LENGTH GAMMA NAIL (K020773)Howmedica Osteonics Corp.2002-04-04
2 PIECE MODULAR HIP STEM (K013106)Howmedica Osteonics Corp.2002-04-03
EBI OMEGA21 SPINAL FIXATION SYSTEM (K020681)Ebi, L.P.2002-04-03
POWER TEK II (K020761)Biomet, Inc.2002-04-03
HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR (K020688)Hydrocision, Inc.2002-04-03
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW (K020674)Blackstone Medical, Inc.2002-04-03
IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET (K020221)Biomet Orthopedics, Inc.2002-04-02
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B (K020043)Arthrex, Inc.2002-04-02
MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM (K020650)Howmedica Osteonics Corp.2002-03-29
GAMMA 3 LAG SCREW (K020677)Howmedica Osteonics Corp.2002-03-29
UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM (K014302)Pisharodi Surgicals, Inc.2002-03-29
RESORBABLE LACTOSORB-L ACL CROSSPIN (K014305)Arthrotek, Inc.2002-03-29
UNIVERSAL BONE PLATE III SYSTEM (UBP III) (K020611)Spinal Concepts, Inc.2002-03-27
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S (K014304)Triage Medical, Inc.2002-03-27
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 (K014243)Triage Medical, Inc.2002-03-26
SMITH & NEPHEW TWINFIX TI QUICK T (K020159)Smith & Nephew, Inc.2002-03-26
X-SERIES BI-METRIC HIP FEMORAL COMPONENTS (K020580)Biomet, Inc.2002-03-22
ODI TALON INTRAMEDULLARY HIP NAIL (K014189)Orthopedic Designs, Inc.2002-03-21
SYNTHES HIGH TIBIAL OSTEOTOMY PLATE (K014197)Synthes (Usa)2002-03-21
MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM (K020522)Depuyacromed2002-03-21
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00 (K014154)Vilex, Inc.2002-03-18
CERASORB ORTHO (K014156)Curasan AG2002-03-18
OPENING/CLOSING WEDGE OSTETOMY PLATES (K014155)Arthrex, Inc.2002-03-18
ADVANCE UNICONDYLAR KNEE SYSTEM (K014171)Wrightmedicaltechnologyinc2002-03-15
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS (K012778)Smith & Nephew, Inc.2002-03-15
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II (K012788)Smith & Nephew, Inc.2002-03-15
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE (K012787)Smith & Nephew, Inc.2002-03-15
COAPT SYSTMES ENDOTINE DEVICE (K014153)Coapt Systems, Inc.2002-03-15
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM (K020097)Stryker Endoscopy2002-03-15
MITEK BIOCRYL INTERFERENCE SCREWS (K013572)Mitek Products2002-03-14
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM (K020446)American Medical Systems, Inc.2002-03-13
HIGHGATE CURVED ROD SYSTEM (K012045)Highgate Orthopaedics2002-03-12
GREAT TOE IMPLANT SYSTEM (K014164)Harmos Orthopaedics, Inc.2002-03-12
OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES (K012377)Corin USA2002-03-11
ENDIUS SPINAL FIXATION SYSTEM (K014090)Endius, Inc.2002-03-11
CONDUIT TCP GRANULES (K014053)Depuyacromed2002-03-08
MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR (K020403)Ebi, L.P.2002-03-08
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) (K014072)Disc-O-Tech Medical Technologies, Ltd.2002-03-08
MASTERGRAFT RESORBABLE CERAMIC GRANULES (K012506)Medtronic Sofamor Danek USA, Inc.2002-03-07
WRISTORE FIXATOR (K012294)Millennium Medical Technologies, Inc.2002-03-04
ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM (K020572)Howmedica Osteonics Corp.2002-03-04
TRIDENT ELEVATED RIM LINER (K020497)Howmedica Osteonics Corp.2002-03-04
MODIFICATION TO EBI XFIX DFS SYSTEM (K014276)Ebi, L.P.2002-03-01
ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS (K012640)Medical Instruments Technology, Inc.2002-02-28
LORENZ SELF DRILLING SCREWS (K013954)Walter Lorenz Surgical, Inc.2002-02-28
EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER (K020291)Exactech, Inc.2002-02-27
SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE (K020352)Unitedstates Surgical2002-02-26
MSD WIRE SYSTEM (K020426)Medtronic Sofamor Danek, Inc.2002-02-26
MEDIAL ROTATION KNEE SYSTEM (K020214)Engineering Consulting Services, Inc.2002-02-26
BIOABSORBABLE INTERFERENCE SCREW MEGAFIX (K013107)Karl Storz Endoscopy2002-02-26
TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER (K013923)Biomet Orthopedics, Inc.2002-02-25
INION CPS BSSO SCREW (K020266)Inion , Ltd.2002-02-22
SLIM GLIDING NAIL SYSTEM (K020240)Plus Orthopedics2002-02-22
WMT MODULAR ULNAR HEAD IMPLANT (K020274)Wrightmedicaltechnologyinc2002-02-22
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189 (K020204)Interpore Cross Intl.2002-02-21
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM (K020196)Sulzer Spine-Tech2002-02-15
MODIFICATION TO PASS SPINAL SYSTEM (K020236)Encore Orthopedics, Inc.2002-02-14
OSTEONICS SPINAL SYSTEM (K020293)Howmedica Osteonics Corp.2002-02-14
ENDIUS CERVICAL PLATE SYSTEM (K014107)Endius, Inc.2002-02-13
AOS CANNULATED BONE SCREW SYSTEM (K014185)Advanced Orthopaedic Solutions, Inc.2002-02-13
SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM (K013979)Spinal Concepts, Inc.2002-02-13
UNI-T SPINAL SYSTEM (K013301)Spine Vision, Inc.2002-02-13
P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM) (K013312)Spine Vision, Inc.2002-02-13
BACFIX SPINAL FIXATION SYSTEM (K013887)Spinal Concepts, Inc.2002-02-12
NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0 (K020295)Implex Corp.2002-02-12
TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 (K020083)Tuta Healthcare Pty Limited2002-02-12
KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP (K020170)Encore Orthopedics, Inc.2002-02-11
CONCERT RADIOPAQUE BONE CEMENT (K013755)Immedica, Inc.2002-02-08
SYNTHES METALLIC SPIKED WASHERS (K013806)Synthes (Usa)2002-02-08
REPICCI II UNICONDYLAR KNEE SYSTEM (K020264)Biomet Orthopedics, Inc.2002-02-08
MODIFICATION TO GEO STRUCTURE (K020048)Interpore Cross Intl.2002-02-06
RIDIDFIX 2.7MM BTB CROSS PIN KIT (K013781)Mitek Products2002-02-06
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM (K020141)Ebi, L.P.2002-02-05
DYNA-LOK CLASSIC SPINAL SYSTEM (K020155)Medtronic Sofamor Danek2002-02-05
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS (K013885)Blackstone Medical, Inc.2002-02-01
MODIFICATION TO ISOBAR SPINAL SYSTEM (K020245)Scien'Tx USA, Inc.2002-02-01
ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM (K013196)Spinal Innovations, LLC2002-01-30
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (K012184)Blackstone Medical, Inc.2002-01-30
PATRIOT PROTRUSIO CAGE (K020076)Biomet Orthopedics, Inc.2002-01-30
SPIKED WASHER (K011583)Synthes (Usa)2002-01-30
BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 (K012702)Endotec, Inc.2002-01-30
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE (K012551)Biomet, Inc.2002-01-30
3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM (K020045)Biomet Orthopedics, Inc.2002-01-30
PYRAMID ANTERIOR PLATE FIXATION SYSTEM (K013665)Medtronic Sofamor Danek, Inc.2002-01-29
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ (K010378)Implex Corp.2002-01-28
DEPUY FEMORAL HEADS (K011533)DePuy Orthopaedics, Inc.2002-01-28
FINGER JOINT PROSTHESIS (K013629)Avanta Orthopaedics, Inc.2002-01-25
UNITRAX MODULAR UNIPOLAR SYSTEM (K014226)Howmedica Osteonics Corp.2002-01-25
T2 FEMORAL NAIL SYSTEM (K014220)Howmedica Osteonics Corp.2002-01-25
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