meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
32
Latest Decision
1999-06-03

Clearances · page 130 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K991482 UNI-CLIP STAPLE New Deal, S.A. JDR Class II 1999-06-03
K991552 SYNTHES PEDIATRIC ROD SYSTEM Synthes (Usa) MNH Class II 1999-06-02
K990717 FIXION INTRAMEDULLARY NAILING SYSTEM Disco-O-Tech Medical Technologies, Ltd. HSB Class II 1999-06-02
K990922 OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR Howmedica Osteonics Corp. KWP Class II 1999-06-02
K991123 PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM Wrightmedicaltechnologyinc LPH Class II 1999-06-01
K990353 STAINLESS STEEL FIXATION PINS Bregma International Trading Company , Ltd. JDW Class II 1999-06-01
K984290 IMPLEX RADIAL HEAD REPLACEMENT SYSTEM Implex Corp. KWI Class II 1999-06-01
K991051 KSEA EPIDUROSCOPE KARL STORZ Endoscopy-America, Inc. HRX Class II 1999-06-01
K990351 BONE SCREWS Bregma International Trading Company , Ltd. HWC Class II 1999-06-01
K991226 FOUNDATION POROUS HIP STEM Encore Orthopedics, Inc. LZO Class II 1999-06-01
K991227 8MM FORGED CEMENTED STEM Encore Orthopedics, Inc. JDI Class II 1999-06-01
K991528 MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR Danek Medical, Inc. MNH Class II 1999-05-28
K990721 ISOLOCK SPINAL SYSTEM Scien'Tx USA, Inc. MNH Class II 1999-05-27
K991732 CENTRAFIX EXTERNAL FIXATOR Owandar Medical, Ltd. JEC Class II 1999-05-21
K991428 ASCENT KNEE SYSTEM Biomet, Inc. JWH Class II 1999-05-21
K991460 MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM Sofamor Danek MNH Class II 1999-05-19
K991364 MODIFICATION TO TENOR SPINAL SYSTEM-PLATES Sofamor Danek USA,Inc. MNH Class II 1999-05-19
K991461 OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT Howmedica Osteonics Corp. JWH Class II 1999-05-17
K990848 TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION Immedica, Inc. LXT Class II 1999-05-17
K991298 BONE MULCH SCREW SYSTEM Biomet, Inc. HWC Class II 1999-05-14
K972774 GAS PLASMA STERILIZATION Zimmer, Inc. JWH Class II 1999-05-05
K984375 OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY Osteonics Corp. KWP Class II 1999-04-30
K983036 SINGLE AXLE TOTAL ELBOW Biomet, Inc. JDC Class II 1999-04-30
K990523 B2C, ESPACE REVISION CUP SYSTEM Turnkey Intergration USA, Inc. LPH Class II 1999-04-30
K983435 ROTORBLADE Li Medical Technologies, Inc. MAI Class II 1999-04-29
K984171 ENDOPEARL Linvatec Corp. MAI Class II 1999-04-29
K991092 EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM Electro-Biology, Inc. KWQ Class II 1999-04-29
K990804 STAYFUSE Pioneer Surgical Technology HWC Class II 1999-04-29
K990821 PROVIDENCE CUP SYSTEM Biopro, Inc. JDI Class II 1999-04-29
K990776 AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM Aap Implantate AG HWC Class II 1999-04-29
K990303 EBI OMEGA 21 SYSTEM Electro-Biology, Inc. KWP Class II 1999-04-29
K990596 DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM Avanta Orthopaedics, Inc. HRS Class II 1999-04-29
K990622 BOLD SCREW New Deal, S.A. HWC Class II 1999-04-29
K991135 SOFT TISSUE SUTURE WASHER Depuy, Inc. HTN Class II 1999-04-29
K991197 VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24 Vilex, Inc. HWC Class II 1999-04-26
K991151 VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW Vilex, Inc. HWC Class II 1999-04-26
K990459 EBI VUECATH ENDOSCOPIC SYSTEN Electro-Biology, Inc. HRX Class II 1999-04-23
K990361 HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU Arthrex, Inc. MAI Class II 1999-04-14
K990999 MODIFICATION OF: EBI SPINELINK SYSTEM Electro-Biology, Inc. MAI Class II 1999-04-14
K990845 MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15 Advanced Spine Fixation Systems, Inc. KWP Class II 1999-04-13
K984227 OMEGA II MODULAR TOTAL HIP SYSTEM Osteoimplant Technology, Inc. JDI Class II 1999-04-08
K990322 PERRY HUMERAL NAIL Pioneer Surgical Technology HSB Class II 1999-04-01
K990307 OMNI-FIX, NAIL SYSTEM Turnkey Intergration USA, Inc. KTW Class II 1999-04-01
K990436 ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM Biodynamic Technologies, Inc. HSB Class II 1999-03-31
K990745 MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM Synthes Spine MNI Class II 1999-03-30
K990708 TITANIUM VERSALOK Wrightmedicaltechnologyinc KWP Class II 1999-03-30
K990657 TRIFIX PEDICLE SPINAL SCREW ASSEMBLY Corin USA MNH Class II 1999-03-26
K982798 OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM Osteonics Corp. KWQ Class II 1999-03-25
K990291 LACTOSORB BONE PIN Biomet, Inc. HTY Class II 1999-03-23
K990392 DEPUY ACE SPIDER PLATE Depuy Ace Medical Co. HRS Class II 1999-03-23
K984578 SYNERGY D2 SPINAL IMPLANTS Interpore Cross Intl. MNI Class II 1999-03-23
K983652 ABLATOR ELECTRODE Linvatec Corp. HRX Class II 1999-03-23
K990118 ISOBAR SPINAL SYSTEM Scien'Tx USA, Inc. MNH Class II 1999-03-22
K982160 HINGED KNEE Encore Orthopedics, Inc. KRO Class II 1999-03-17
K990481 ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM Biodynamic Technologies, Inc. HRS Class II 1999-03-17
K990513 ULTIMAX CORTICAL BONE SCREWS Biodynamic Technologies, Inc. HWC Class II 1999-03-17
K983835 IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA Implex Corp. JWH Class II 1999-03-15
K990019 DRG MEDIUM SCREW SYSTEM Dolphin Medical Technologies, Inc. HWC Class II 1999-03-15
K990152 OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER Howmedica Osteonics Corp. HSB Class II 1999-03-15
K990309 PLUS FRACTURE HEAD PROSTHESIS Plus Orthopedics KWL Class II 1999-03-15
K984492 TIGRAN HIP PROSTHESIS Ponmed , Ltd. LPH Class II 1999-03-15
K984190 BACK-ON-TRAC, MODEL 101BOT Back-On-Track, Inc. HST Class I 1999-03-15
K990598 OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD Howmedica Osteonics Corp. KWS Class II 1999-03-15
K990369 SYNERGY CEMENTED HIP STEM Smith & Nephew, Inc. JDI Class II 1999-03-12
K983843 BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B Arthrex, Inc. MAI Class II 1999-03-12
K990603 MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM Danek Medical, Inc. KWQ Class II 1999-03-10
K981996 TITANIUM FEMORAL COMPONENT Biomet, Inc. JWH Class II 1999-03-10
K984602 SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM Syntec Scientific Corp. HSB Class II 1999-03-05
K984623 MAXIM REMOVABLE MOLDED POLY TIBIA Biomet, Inc. JWH Class II 1999-03-05
K990295 BONE ANCHOR SYSTEM III (BAS III) Boston Scientific Corp MBI Class II 1999-03-05
K990156 MULTITAK SS BUTTONS Bonutti Research MBI Class II 1999-03-05
K984357 TRANSFX EXTERNAL FIXATION SYSTEM Immedica, Inc. LXT Class II 1999-03-04
K982996 POLYMER OBL SB ANCHOR / SUTURE COMBINATION Orthopaedic Biosystems, Ltd. JDR Class II 1999-03-04
K990131 PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE Interpore Cross Intl. MQV Class II 1999-03-02
K984364 SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820 Syntec Scientific Corp. KTT Class II 1999-03-02
K984543 SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25 Syntec Scientific Corp. HSB Class II 1999-03-01
K984490 SUTURELESS ANCHOR Innovasive Devices, Inc. MAI Class II 1999-03-01
K990136 ANATOMICA GLENOID COMPONENT Sulzer Orthopedics, Inc. KWS Class II 1999-03-01
K982663 STIMULAN- CALCIUM SULFATE BONE VOID FILLER Encore Orthopedics, Inc. MQV Class II 1999-02-26
K990443 ARTHRO-SURGIMAT-2000 ECU W.O.M. World of Medicine GmbH HRX Class II 1999-02-26
K983834 ECHELON HIP STEM Smith & Nephew, Inc. LPH Class II 1999-02-24
K990003 J-SERIES OMEGA TOTAL HIP SYSTEM Osteoimplant Technology, Inc. LPH Class II 1999-02-24
K984432 DALL-MILES CABLE GRIP (A-GRIP) Howmedica Osteonics Corp. JDQ Class II 1999-02-24
K984585 OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE Osteonics Corp. KWL Class II 1999-02-24
K984251 XIA SPINE SYSTEM Howmedica, Inc. KWQ Class II 1999-02-24
K983144 FLEXPOSURE RETRACTOR Endius, Inc. HRX Class II 1999-02-24
K990203 OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS Osteonics Corp. MEH Class II 1999-02-18
K990032 MODULAR PROTUSIO CUP Biomet, Inc. JDI Class II 1999-02-18
K984296 LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT Biomet, Inc. LPH Class II 1999-02-18
K990137 ANATOMICA HUMERAL STEM/HEAD COMPONENTS Sulzer Orthopedics, Inc. KWS Class II 1999-02-18
K984498 SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM Synthes (Usa) KTT Class II 1999-02-18
K990094 KMI WRIST FUSION SYSTEM Kinetikos Medical, Inc. HRS Class II 1999-02-18
K990160 MICROTAC-BONE ANCHOR SYSTEM Influence, Inc. MBI Class II 1999-02-16
K990005 SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM Spinal Concepts, Inc. KWQ Class II 1999-02-12
K984408 130 MODIFIED INTEGRAL FEMORAL COMPONENT Biomet, Inc. LPH Class II 1999-02-12
K984442 AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 Hand Biomechanics Lab, Inc. JEC Class II 1999-02-12
K984154 APF POROUS COATED LINE EXTENSION Biomet, Inc. JDI Class II 1999-02-11
K984202 HOWMEDICA HUMERAL INTERCALARY SYSTEM Howmedica, Inc. HSD Class II 1999-02-05
K990197 MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM Exactech, Inc. MEH Class II 1999-02-04
K984209 STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED Biomet, Inc. HWC Class II 1999-02-03

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