meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
34
Latest Decision
2001-04-05

Clearances · page 124 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K010664 COPELAND RESURFACING HUMERAL HEADS Biomet Manufacturing, Inc. HSD Class II 2001-04-05
K010685 MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE) Zimmer, Inc. HSX Class II 2001-04-02
K002829 DJ ORTHOPEDICS FEMORAL ANCHOR Dj Orthopedics, LLC MBI Class II 2001-03-26
K010515 MODIFICATION TO SYNERGY SPINAL SYSTEM Interpore Cross Intl. KWP Class II 2001-03-22
K003960 DJ ORTHOPEDICS TIBIAL ANCHOR Dj Orthopedics, LLC MBI Class II 2001-03-21
K003971 AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR Axya Medical, Inc. MBI Class II 2001-03-21
K003951 PECTOFIX STERNAL REPAIR WIRE Pectofix, Inc. JDQ Class II 2001-03-21
K010560 PORTRAIT FEMORAL COMPONENT Biomet, Inc. LZO Class II 2001-03-20
K003923 APEX MODULAR ZIRCONIA FEMORAL HEAD Apex Surgical, LLC LZO Class II 2001-03-20
K001535 ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION Ortho Tec, LLC KWP Class II 2001-03-20
K001581 LACTOSORB 5.0 MM WASHER Biomet, Inc. HWC Class II 2001-03-20
K010310 MODIFICATION TO TRIDENT ALL POLY CUP Howmedica Osteonics Corp. JDI Class II 2001-03-20
K003910 NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS Zimmer, Inc. JWH Class II 2001-03-19
K003976 BAUMER MULLER HIP PROSTHESIS Baumer, S.A JDI Class II 2001-03-19
K003984 SUPER REVO SUTURE ANCHOR Linvatec Corp. MAI Class II 2001-03-19
K010535 TRIFIX SPINAL FIXATION SYSTEM Endius, Inc. MNH Class II 2001-03-19
K003975 BAUMER CEMENTED HIP PROSTHESIS Baumer, S.A JDI Class II 2001-03-19
K003911 TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE) Terray Corp. KWP Class II 2001-03-13
K001354 MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM Biomedical Ent., Inc. JDR Class II 2001-03-13
K010434 OPTETRAK B-SERIES TOTAL KNEE SYSTEM Exactech, Inc. JWH Class II 2001-03-13
K010437 MODIFICATION TO EBI XFIX DFS RAIL SYSTEM Ebi, L.P. KTT Class II 2001-03-13
K003816 ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM Arthrex, Inc. HWC Class II 2001-03-09
K010367 MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM DePuy Orthopaedics, Inc. LPH Class II 2001-03-09
K002274 SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW Smith & Nephew, Inc. HWC Class II 2001-03-07
K003758 ALLOFIT ACETABULAR SYSTEM Sulzer Orthopedics, Inc. KWA Class III 2001-03-07
K002088 SHAVER ABLATOR Linvatec Corp. HRX Class II 2001-03-06
K003893 VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X Oratec Interventions, Inc. HRX Class II 2001-03-01
K003875 TI-REPLICA HIP STEM DePuy Orthopaedics, Inc. LPH Class II 2001-03-01
K003801 ANATOMICAL PRESS-FIT HUMERAL STEM Sulzer Orthopedics, Inc. KWS Class II 2001-02-28
K003649 TRITON HIP SYSTEM Hayes Medical, Inc. LWJ Class II 2001-02-23
K010249 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MNH Class II 2001-02-23
K003648 FREEDLAND TENSION SYSTEM Etzem Technologies, Inc. MBI Class II 2001-02-23
K003629 MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 Terray Corp. KWD Class II 2001-02-22
K003700 SYNTHES HAMSTRING LOOP Synthes (Usa) HWC Class II 2001-02-20
K003659 PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 Bionx Implants, Inc. HTY Class II 2001-02-20
K002406 MITEK 2GII MENISCAL REPAIR SYSTEM Mitek Products MAI Class II 2001-02-15
K010243 TRI-FIT FEMORAL STEM Corin USA LWJ Class II 2001-02-15
K003599 SMITH & NEPHEW SUTURE ANCHOR Smith & Nephew, Inc. HWC Class II 2001-02-15
K004032 PERFECTA AND EXTEND Wrightmedicaltechnologyinc LPH Class II 2001-02-15
K003572 DYONICS CONTROL RF SYSTEM Smith & Nephew, Inc. HRX Class II 2001-02-15
K001147 ENHANCED POLYETHYLENE KNEE PROSTHESES Howmedica Osteonics Corp. JWH Class II 2001-02-15
K010246 KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A Kyphon, Inc. HRX Class II 2001-02-14
K003695 MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES Micro-Medical Devices, Inc. HRX Class II 2001-02-14
K010212 OFFSET TIBIAL TRAY Biomet, Inc. MBV Class II 2001-02-14
K003566 COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS Smith & Nephew, Inc. KWS Class II 2001-02-14
K010120 MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S Exactech, Inc. LPH Class II 2001-02-09
K010179 EBI VUECATH SPINAL ENDOSCOPIC SYSTEM Ebi, L.P. HRX Class II 2001-02-09
K003800 AML HIP PROSTHESIS DePuy Orthopaedics, Inc. LPH Class II 2001-02-09
K003743 SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM Synthes (Usa) MAI Class II 2001-02-09
K010121 STERILE BUTTON PLATE Synthes (Usa) MBI Class II 2001-02-09
K010282 LATERAL OFFSET PROTRACT PRESS FIT HIP STEM Stelkast Company LPH Class II 2001-02-09
K003641 BIOLOK SCREW, BIOSTEON SCREW Biocomposites, Ltd. HWC Class II 2001-02-08
K010241 PROTRACT PRESS FIT HIP STEM-HA COATED Stelkast Company LPH Class II 2001-02-08
K000943 CEMEX SYSTEM GUN APPLICATION VERSION Exactech, Inc. LOD Class II 2001-02-08
K003496 CANNULATED SCREW SYSTEM Pioneer Surgical Technology HTN Class II 2001-02-08
K003666 TAPER-FIT TOTAL HIP SYSTEM Corin USA JDI Class II 2001-02-08
K003478 TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310 Zimmer, Inc. LPH Class II 2001-02-05
K010081 ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS Exactech, Inc. KWY Class II 2001-02-05
K010003 EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM Ebi, L.P. KWQ Class II 2001-01-31
K003397 COLLES C SERIES FRAME STERILE PACK DePuy Orthopaedics, Inc. KTT Class II 2001-01-29
K002652 SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII Stryker Corp. LOD Class II 2001-01-26
K004013 IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY Implex Corp. JWH Class II 2001-01-25
K003250 FMP METAL/METAL ACETABULAR INSERT Encore Orthopedics, Inc. KWA Class III 2001-01-25
K003351 PARSFIX CABLE-SCREW SYSTEM Spinal Concepts, Inc. KWP Class II 2001-01-24
K003316 OTI CERAMIC FEMORAL HEAD SYSTEM Osteoimplant Technology, Inc. LZO Class II 2001-01-19
K003253 BIOMET'S MINIMALLY CONSTRAINED ELBOW Biomet, Inc. JDC Class II 2001-01-12
K010027 MAXIM KNEE SYSTEM Biomet, Inc. JWH Class II 2001-01-12
K003970 CONTOUR LABRAL NAIL, MODEL 533520A Bionx Implants, Inc. MAI Class II 2001-01-12
K003273 LACTOSORB SCREW ANCHOR Biomet, Inc. MAI Class II 2001-01-11
K003848 HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST Howmedica Osteonics Corp. JEC Class II 2001-01-11
K003237 U2 HIP STEM, TI POROUS COATED United Orthopedic Corp. LPH Class II 2001-01-10
K003199 TRIAD II MODULAR TOTAL HIP SYSTEM Osteoimplant Technology, Inc. LPH Class II 2001-01-10
K003227 BIO-ABSORBABLE CORKSCREW MODEL AR-1920B Arthrex, Inc. MAI Class II 2001-01-08
K003822 ISOLA CLOSED DUAL ROD CONNECTOR Depuyacromed KWP Class II 2001-01-08
K003269 UNICONDYLAR INTERPOSITIONAL SPACER Sulzer Orthopedics, Inc. HSH Class II 2001-01-04
K003155 VERTEBRAL BODY REPLACEMENT Osteotech, Inc. MQP Class II 2001-01-04
K003898 EBI VUECATH SPINAL ENDOSCOPIC SYSTEM Ebi, L.P. HRX Class II 2001-01-04
K003832 SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM Sulzer Orthopedics, Inc. KWS Class II 2001-01-04
K003764 MODIFICATION TO EBI SPINELINK SYSTEM Ebi, L.P. MNH Class II 2001-01-02
K003240 BIOMET EXTERNAL WRIST PLATE Biomet, Inc. LXT Class II 2000-12-29
K003212 FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) Disco-O-Tech Medical Technologies, Ltd. JDS Class II 2000-12-28
K003215 MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) Disco-O-Tech Medical Technologies, Ltd. JDS Class II 2000-12-27
K000641 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MNH Class II 2000-12-22
K003728 MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM Tornier KWS Class II 2000-12-20
K002923 DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM Howmedica Osteonics Corp. LXT Class II 2000-12-18
K003211 HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING Howmedica Osteonics Corp. LXT Class II 2000-12-15
K002747 REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS Smith & Nephew, Inc. LPH Class II 2000-12-15
K003447 PROTRACT PRESS FIT HIP STEM Stelkast Company LPH Class II 2000-12-15
K003797 ACE AIM TTC FUSION NAIL DePuy Orthopaedics, Inc. HSB Class II 2000-12-15
K003018 TITAN TIBIAL NAIL Howmedica Osteonics Corp. HSB Class II 2000-12-15
K002733 SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM Depuyacromed KWP Class II 2000-12-15
K003205 TRANSFX ANGLED RODS Immedica, Inc. LXT Class II 2000-12-15
K003363 M2A 32MM TAPER SYSTEM Biomet, Inc. KWY Class II 2000-12-15
K994337 VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER Orthovita Co. MQV Class II 2000-12-14
K003044 COPELAND RESURFACING HEADS Biomet, Inc. HSD Class II 2000-12-13
K003523 DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS DePuy Orthopaedics, Inc. KWA Class III 2000-12-13
K003016 PRO-FEMUR R Wrightmedicaltechnologyinc LWJ Class II 2000-12-13
K001254 ORTHOMATRIX, INC. CERCLAGE SYSTEM Orthomatrix, Inc. JDQ Class II 2000-12-13
K002996 SYNERGY HA COATED POROUS FEMORAL STEMS Smith & Nephew, Inc. MEH Class II 2000-12-11
K001956 TRIDENT ALL POLY CUP Howmedica Osteonics Corp. JDI Class II 2000-12-11

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