meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
31
Latest Decision
2000-02-01

Clearances · page 128 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K993910 TAC' PIN New Deal, S.A. JDW Class II 2000-02-01
K993713 RIM-FIX, ACETABULAR CUP Surgical Implants, Inc. JDI Class II 2000-01-28
K990340 ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU Arthrex, Inc. MAI Class II 2000-01-28
K991162 BIOLOX ALUMINA CERAMIC FEMORAL HEAD Smith & Nephew, Inc. LZO Class II 2000-01-28
K992403 MRP-TITAN Rotec Medizintechnik GmbH LZO Class II 2000-01-21
K993768 CITATION TMZF HA STEM Howmedica Osteonics Corp. MEH Class II 2000-01-21
K994070 REVELATION POROUS HIP STEM Encore Orthopedics, Inc. LPH Class II 2000-01-20
K993736 EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT Exactech, Inc. LPH Class II 2000-01-20
K991862 MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS) Micomed GmbH MNI Class II 2000-01-13
K990987 BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B Arthrex, Inc. MAI Class II 2000-01-13
K993657 ACUMED SUTURE ANCHOR Acu Med, Inc. MBI Class II 2000-01-13
K993551 SOCON SPINAL SYSTEM Aesculap, Inc. MNH Class II 2000-01-13
K992396 BIORCI SCREW Smith & Nephew Endoscopy, Inc. HWC Class II 2000-01-12
K993465 DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE Depuy, Inc. HRS Class II 2000-01-11
K994269 TITAN RC TACK Innovasive Devices, Inc. MAI Class II 2000-01-10
K991962 EIS DYNAMIC MEMORY STAPLES SYSTEM Groupe Lepine JDR Class II 2000-01-10
K994326 ASCENT KNEE SYSTEM Biomet Manufacturing, Inc. KWH Class II 2000-01-07
K993873 ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD Alphatec Mfg., Inc. KTT Class II 2000-01-03
K993030 MODIFICATION TO ISOLA SPINAL SYSTEM Depuyacromed KWQ Class II 1999-12-29
K990959 K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM Spineology, Inc. KWQ Class II 1999-12-27
K994038 MODULAR REACH HIP Biomet, Inc. LPH Class II 1999-12-22
K994187 SYNTHES CERVIFIX SYSTEM Synthes (Usa) KWP Class II 1999-12-21
K990849 DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS) Howmedica Osteonics Corp. LPH Class II 1999-12-20
K993975 ABSOLUTE ABSORBABLE INTERFERENCE SCREW Innovasive Devices, Inc. HWC Class II 1999-12-20
K993402 OPUS SPINAL SYSTEM Howmedica Osteonics Corp. MNI Class II 1999-12-20
K993956 TITANIUM PEDIATRIC FEMORAL NAIL Biomet, Inc. HSB Class II 1999-12-20
K993289 SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM Smith & Nephew, Inc. KTT Class II 1999-12-20
K992355 LACTOSORB TRAUMA PLATING SYSTEM Biomet, Inc. HRS Class II 1999-12-20
K991964 EIS THREADED SCREW FRACTURE FIXATION Groupe Lepine HWC Class II 1999-12-20
K993371 SADDLE SHAPED PATELLA Wrightmedicaltechnologyinc JWH Class II 1999-12-20
K993115 MULTITAK SS Bonutti Research, Inc. MAI Class II 1999-12-17
K993926 OMNIAXIAL CONNECTOR Ortho Tec, LLC MNH Class II 1999-12-17
K993855 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM Danek Medical, Inc. KWQ Class II 1999-12-15
K993099 BREMER HALO SYSTEM TITANIUM SKULL PIN Depuyacromed JEC Class II 1999-12-15
K993886 EBI XFIX VISION FIXATION SYSTEM Ebi, L.P. KTT Class II 1999-12-14
K993339 ENDOPEARL WITH THREADER Linvatec Corp. MAI Class II 1999-12-10
K993074 SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525 Bionx Implants, Ltd. MAI Class II 1999-12-10
K993822 EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM Ebi, L.P. KWQ Class II 1999-12-10
K993106 SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES) Smith & Nephew, Inc. HRS Class II 1999-12-09
K991882 NEXFLEX TOTAL KNEE SYSTEM Nexmed, Inc. JWH Class II 1999-12-08
K993073 SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 Bionx Implants, Ltd. MAI Class II 1999-12-06
K993808 SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220 Interpore Cross Intl. MNH Class II 1999-12-06
K993692 DURACON INSET PATELLA, 25MM Howmedica Osteonics Corp. JWH Class II 1999-12-02
K993043 MS-30 FEMORAL STEM Sulzer Orthopedics, Inc. LZO Class II 1999-12-02
K991656 AED ARTHROSCOPE National Advanced Endoscopy Devices, Inc. HRX Class II 1999-12-02
K993261 TALON ANCHOR SNAP-PAK Mitek Products MBI Class II 1999-12-02
K993569 APR METASUL ACETABULAR INSERT Sulzermedica KWA Class III 1999-12-01
K992235 ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS Corin USA LZO Class II 1999-11-23
K993286 PIONEER SILICOAT STERNAL CABLE Pioneer Surgical Technology JDQ Class II 1999-11-23
K992920 EBI SPINELINK SYSTEM Ebi, L.P. MNI Class II 1999-11-23
K993540 ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE KARL STORZ Endoscopy-America, Inc. HRX Class II 1999-11-22
K993061 STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM Stryker Instruments MAI Class II 1999-11-19
K993649 EBI XFIX DFS WRISTFIX SYSTEM Ebi, L.P. KTT Class II 1999-11-19
K993352 CROSSFIRE SYSTEM 12 ACETABULAR INSERTS Howmedica Osteonics Corp. LPH Class II 1999-11-19
K992885 VERSALOK LOW BACK FIXATION SYSTEM Osteotech, Inc. KWP Class II 1999-11-19
K993082 EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT Exactech, Inc. LPH Class II 1999-11-19
K993603 WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW Howmedica Osteonics Corp. HSB Class II 1999-11-19
K992945 RCI FIXATION SCREWS (WITH ASSORTED SIZES) Smith & Nephew, Inc. HWC Class II 1999-11-18
K991024 BONE BULLET SUTURE ANCHOR Linvatec Corp. HWC Class II 1999-11-16
K993067 SILHOUETTE SPINAL FIXATION SYSTEM Sulzer Spine-Tech KWP Class II 1999-11-16
K992792 XIA SPINAL SYSTEM C-C ADAPTOR Howmedica Osteonics Corp. KWQ Class II 1999-11-16
K993510 MODIFIED BMP TROCHANTERIC PLATES Biomet, Inc. HRS Class II 1999-11-16
K993670 MODIFIED LONG LENGTH GAMMA NAIL Howmedica Osteonics Corp. HSB Class II 1999-11-16
K993601 HOWMEDICA OSTEONICS FEMORAL HEADS Howmedica Osteonics Corp. LWJ Class II 1999-11-16
K992287 FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM Howmedica Osteonics Corp. HSX Class II 1999-11-16
K992234 THE TAPER-FIT TOTAL HIP SYSTEM Corin USA JDG Class II 1999-11-10
K991052 FS 1000 KNEE SYSTEM Renaissance Instruments, LLC JWH Class II 1999-11-10
K993021 METRX SYSTEM Surgical Navigation Technologies, Inc. HRX Class II 1999-11-10
K993453 MENISCUS ARROW, MODELS 531110, 531113, 531116 Bionx Implants, Ltd. MAI Class II 1999-11-09
K991662 TITANIUM HARTSHILL SYSTEM Surgicraft , Ltd. KWP Class II 1999-11-08
K991326 ISOBAR SEMI-RIGID SPINAL SYSTEM Scien'Tx USA, Inc. MNI Class II 1999-11-08
K992738 ISOBAR SPINAL SYSTEM Encore Orthopedics, Inc. MNI Class II 1999-11-08
K992961 LORENZ SMALL FRAGMENT SYSTEM Walter Lorenz Surgical, Inc. HRS Class II 1999-11-08
K992970 DIGIT WIDGET Hand Biomechanics Lab, Inc. JDW Class II 1999-11-08
K992621 ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES Advanced Diagnostics & Interventions HRX Class II 1999-11-08
K992656 DEPUY TOTAL ELBOW SYSTEM DePuy Orthopaedics, Inc. JDC Class II 1999-11-05
K992891 SYNTHES CERCLAGE POSITIONING PIN Synthes (Usa) JDQ Class II 1999-11-02
K992583 MASS (MICRO-ACCESS SPINE SYSTEM) Omni-Tract Surgical, Div. Minn. Scientific, Inc. HRX Class II 1999-10-29
K993373 ROTORBLADE SUTURE ANCHOR Li Medical Technologies, Inc. MAI Class II 1999-10-27
K992784 NEXT GENERATION RODDING SYSTEM United States Surgical, A Division of Tyco Healthc KWQ Class II 1999-10-27
K992667 ZMR HIP SYSTEM-REVISION TAPER Zimmer, Inc. LPH Class II 1999-10-27
K992617 HEX BUTTON Pioneer Surgical Technology HTN Class II 1999-10-27
K992616 SDB CERCLAGE SYSTEM Pioneer Surgical Technology JDQ Class II 1999-10-27
K993009 HYDROCISION ARTHROJET SYSTEM WITH CAUTERY Hydrocision, Inc. HRX Class II 1999-10-25
K990397 FLEXIBLE FIBERSCOPES & ACCESSORIES Richard Wolf Medical Instruments Corp. HRX Class II 1999-10-25
K992837 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP) Synthes (Usa) KTW Class II 1999-10-25
K991026 REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS Smith & Nephew, Inc. LPH Class II 1999-10-22
K993181 HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS Howmedica Osteonics Corp. KWQ Class II 1999-10-22
K992899 BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS Biomet, Inc. KWS Class II 1999-10-21
K992394 BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT Endotec, Inc. HSD Class II 1999-10-15
K990986 CONTOUR SPINAL SYSTEM Ortho Development Corp. KWP Class II 1999-10-14
K992458 RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454 Innovasive Devices, Inc. MBI Class II 1999-10-14
K993159 MAXIM KNEE SYSTEM Biomet, Inc. JWH Class II 1999-10-14
K992369 SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22 Interpore Cross Intl. MNI Class II 1999-10-13
K992333 EBI OMEGA 21 SYSTEM Electro-Biology, Inc. MNI Class II 1999-10-08
K993077 HOWMEDICA OSTEONICS RESTORATION HA HIP STEM Howmedica Osteonics Corp. MEH Class II 1999-10-08
K993025 MODIFICATION TO BONE MULCH SCREW SYSTEM Biomet, Inc. HWC Class II 1999-10-08
K992377 RC TACK Innovasive Devices, Inc. MBI Class II 1999-10-08
K992409 THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ Implex Corp. JDI Class II 1999-10-08
K993004 ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW Howmedica Osteonics Corp. JDS Class II 1999-10-06

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