meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
34
Latest Decision
2002-03-21

Clearances · page 120 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K014197 SYNTHES HIGH TIBIAL OSTEOTOMY PLATE Synthes (Usa) HRS Class II 2002-03-21
K014189 ODI TALON INTRAMEDULLARY HIP NAIL Orthopedic Designs, Inc. JDS Class II 2002-03-21
K014156 CERASORB ORTHO Curasan AG MQV Class II 2002-03-18
K014154 VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00 Vilex, Inc. HWC Class II 2002-03-18
K014155 OPENING/CLOSING WEDGE OSTETOMY PLATES Arthrex, Inc. HRS Class II 2002-03-18
K012778 VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS Smith & Nephew, Inc. JWH Class II 2002-03-15
K014153 COAPT SYSTMES ENDOTINE DEVICE Coapt Systems, Inc. HWC Class II 2002-03-15
K014171 ADVANCE UNICONDYLAR KNEE SYSTEM Wrightmedicaltechnologyinc HRY Class II 2002-03-15
K012788 VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II Smith & Nephew, Inc. KWS Class II 2002-03-15
K012787 VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE Smith & Nephew, Inc. LPH Class II 2002-03-15
K020097 STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM Stryker Endoscopy JDW Class II 2002-03-15
K013572 MITEK BIOCRYL INTERFERENCE SCREWS Mitek Products HWC Class II 2002-03-14
K020446 MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM American Medical Systems, Inc. HWC Class II 2002-03-13
K014164 GREAT TOE IMPLANT SYSTEM Harmos Orthopaedics, Inc. KWD Class II 2002-03-12
K012045 HIGHGATE CURVED ROD SYSTEM Highgate Orthopaedics KWQ Class II 2002-03-12
K014090 ENDIUS SPINAL FIXATION SYSTEM Endius, Inc. KWP Class II 2002-03-11
K012377 OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES Corin USA HSD Class II 2002-03-11
K020403 MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR Ebi, L.P. KTT Class II 2002-03-08
K014072 FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) Disc-O-Tech Medical Technologies, Ltd. KWY Class II 2002-03-08
K014053 CONDUIT TCP GRANULES Depuyacromed MQV Class II 2002-03-08
K012506 MASTERGRAFT RESORBABLE CERAMIC GRANULES Medtronic Sofamor Danek USA, Inc. MQV Class II 2002-03-07
K020572 ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM Howmedica Osteonics Corp. MEH Class II 2002-03-04
K012294 WRISTORE FIXATOR Millennium Medical Technologies, Inc. KTT Class II 2002-03-04
K020497 TRIDENT ELEVATED RIM LINER Howmedica Osteonics Corp. LPH Class II 2002-03-04
K014276 MODIFICATION TO EBI XFIX DFS SYSTEM Ebi, L.P. KTT Class II 2002-03-01
K012640 ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS Medical Instruments Technology, Inc. HRX Class II 2002-02-28
K013954 LORENZ SELF DRILLING SCREWS Walter Lorenz Surgical, Inc. HWC Class II 2002-02-28
K020291 EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER Exactech, Inc. JDI Class II 2002-02-27
K020214 MEDIAL ROTATION KNEE SYSTEM Engineering Consulting Services, Inc. JWH Class II 2002-02-26
K020426 MSD WIRE SYSTEM Medtronic Sofamor Danek, Inc. KWP Class II 2002-02-26
K020352 SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE Unitedstates Surgical HWC Class II 2002-02-26
K013107 BIOABSORBABLE INTERFERENCE SCREW MEGAFIX Karl Storz Endoscopy HWC Class II 2002-02-26
K013923 TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER Biomet Orthopedics, Inc. HSB Class II 2002-02-25
K020266 INION CPS BSSO SCREW Inion , Ltd. HWC Class II 2002-02-22
K020240 SLIM GLIDING NAIL SYSTEM Plus Orthopedics KTT Class II 2002-02-22
K020274 WMT MODULAR ULNAR HEAD IMPLANT Wrightmedicaltechnologyinc KXE Class II 2002-02-22
K020204 TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189 Interpore Cross Intl. MQP Class II 2002-02-21
K020196 MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM Sulzer Spine-Tech MNH Class II 2002-02-15
K020236 MODIFICATION TO PASS SPINAL SYSTEM Encore Orthopedics, Inc. KWP Class II 2002-02-14
K020293 OSTEONICS SPINAL SYSTEM Howmedica Osteonics Corp. MNH Class II 2002-02-14
K013979 SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM Spinal Concepts, Inc. KWQ Class II 2002-02-13
K014185 AOS CANNULATED BONE SCREW SYSTEM Advanced Orthopaedic Solutions, Inc. HWC Class II 2002-02-13
K014107 ENDIUS CERVICAL PLATE SYSTEM Endius, Inc. KWQ Class II 2002-02-13
K013301 UNI-T SPINAL SYSTEM Spine Vision, Inc. MNI Class II 2002-02-13
K013312 P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM) Spine Vision, Inc. KWP Class II 2002-02-13
K020083 TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 Tuta Healthcare Pty Limited HRX Class II 2002-02-12
K020295 NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0 Implex Corp. JWH Class II 2002-02-12
K013887 BACFIX SPINAL FIXATION SYSTEM Spinal Concepts, Inc. MNH Class II 2002-02-12
K020170 KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP Encore Orthopedics, Inc. LPH Class II 2002-02-11
K013806 SYNTHES METALLIC SPIKED WASHERS Synthes (Usa) HTN Class II 2002-02-08
K020264 REPICCI II UNICONDYLAR KNEE SYSTEM Biomet Orthopedics, Inc. HRY Class II 2002-02-08
K013755 CONCERT RADIOPAQUE BONE CEMENT Immedica, Inc. LOD Class II 2002-02-08
K013781 RIDIDFIX 2.7MM BTB CROSS PIN KIT Mitek Products HTY Class II 2002-02-06
K020048 MODIFICATION TO GEO STRUCTURE Interpore Cross Intl. MQP Class II 2002-02-06
K020155 DYNA-LOK CLASSIC SPINAL SYSTEM Medtronic Sofamor Danek KWP Class II 2002-02-05
K020141 MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM Ebi, L.P. KTT Class II 2002-02-05
K020245 MODIFICATION TO ISOBAR SPINAL SYSTEM Scien'Tx USA, Inc. MNH Class II 2002-02-01
K013885 BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS Blackstone Medical, Inc. MNI Class II 2002-02-01
K012702 BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 Endotec, Inc. JWH Class II 2002-01-30
K020076 PATRIOT PROTRUSIO CAGE Biomet Orthopedics, Inc. JDI Class II 2002-01-30
K020045 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM Biomet Orthopedics, Inc. KWT Class II 2002-01-30
K011583 SPIKED WASHER Synthes (Usa) HTN Class II 2002-01-30
K012551 LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE Biomet, Inc. KWI Class II 2002-01-30
K012184 BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM Blackstone Medical, Inc. KWQ Class II 2002-01-30
K013196 ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM Spinal Innovations, LLC KWP Class II 2002-01-30
K013665 PYRAMID ANTERIOR PLATE FIXATION SYSTEM Medtronic Sofamor Danek, Inc. KWQ Class II 2002-01-29
K010378 HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ Implex Corp. MQP Class II 2002-01-28
K011533 DEPUY FEMORAL HEADS DePuy Orthopaedics, Inc. LZO Class II 2002-01-28
K014226 UNITRAX MODULAR UNIPOLAR SYSTEM Howmedica Osteonics Corp. KWL Class II 2002-01-25
K013629 FINGER JOINT PROSTHESIS Avanta Orthopaedics, Inc. KYJ Class II 2002-01-25
K014267 BUTTERFLY PLATE FIXATION SYSTEM Medtronic Sofamor Danek, Inc. KWP Class II 2002-01-25
K014229 MODIFICATION TO OPUS SPINAL SYSTEM Howmedica Osteonics Corp. MNH Class II 2002-01-25
K014220 T2 FEMORAL NAIL SYSTEM Howmedica Osteonics Corp. HSB Class II 2002-01-25
K013558 BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW Blackstone Medical, Inc. KWQ Class II 2002-01-23
K013685 PLLA CANNULATED INTERFERENCE SCREW Future Medical Systems, Inc. HWC Class II 2002-01-18
K014194 MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM Ebi, L.P. KTT Class II 2002-01-17
K014145 MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131 Interpore Cross Intl. MQP Class II 2002-01-17
K013490 CEMENTED CALCAR HIP SYSTEM Encore Orthopedics, Inc. LPH Class II 2002-01-17
K013513 DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE Pain Concepts, Inc. HRX Class II 2002-01-17
K014137 MODIFICATION TO EBI OMEGA 21 SYSTEM Ebi, L.P. MNH Class II 2002-01-16
K013447 ISOBAR SPINAL SYSTEM Scien'Tx USA, Inc. KWP Class II 2002-01-15
K013442 PASS SPINAL SYSTEM Encore Orthopedics, Inc. KWP Class II 2002-01-15
K013439 ANTERIOR CERVICAL PLATE SYSTEM Scien'Tx USA, Inc. KWQ Class II 2002-01-14
K013429 ACTAEON PROBE Osteobiologics, Inc. NGR Class II 2002-01-11
K013415 SYNTHES ANKLE ARTHRODESIS PLATE Synthes (Usa) HRS Class II 2002-01-11
K014049 EPOCA CODR STEM AND HEAD Stelkast Company KWT Class II 2002-01-09
K013385 NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE Zimmer, Inc. KRO Class II 2002-01-09
K013775 TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM Stryker Leibinger HRS Class II 2002-01-08
K011202 MSI BIPOLAR SHEATH Medical Scientific, Inc. HRX Class II 2001-12-31
K013991 PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS Zimmer, Inc. JWH Class II 2001-12-27
K011887 AVALON CUP SYSTEM Orthopedic Source, Inc. JDI Class II 2001-12-27
K011406 SPINAL MESH SYSTEM Medtronic Sofamor Danek, Inc. MQP Class II 2001-12-27
K014076 MODIFICATION TO TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MNH Class II 2001-12-27
K013563 LONG TROCHANTERIC NAIL SYSTEM DePuy Orthopaedics, Inc. HSB Class II 2001-12-27
K013527 MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM Synthes (Usa) HTO Class I 2001-12-21
K013340 RT-PLUS KNEE ADDITIONAL COMPONENTS Plus Orthopedics KRO Class II 2001-12-20
K011897 NORIAN SRS BONE VOID FILLER Synthes (Usa) MQV Class II 2001-12-20
K013132 SIGN IM NAIL Surgical Implant Generation Network (Sign) HSB Class II 2001-12-20
K013475 TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING Howmedica Osteonics Corp. LPH Class II 2001-12-20
K013424 INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND Hand Innovations, Inc. HTY Class II 2001-12-20

17,115 clearances in the Orthopedic panel. Data: openFDA.