meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
39
Latest Decision
2005-09-14

Clearances · page 105 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K052247 NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX Abbott Spine, Inc. KWP Class II 2005-09-14
K050085 OSTEOPAL V Heraeus Kulzer,GmbH LOD Class II 2005-09-14
K052152 B-BOP PLATE New Deal, S.A. HRS Class II 2005-09-13
K051665 SYNTHES VECTRA-T SYSTEM Synthes Spine KWQ Class II 2005-09-09
K052150 VOLAR PLATE SYSTEM Dvo Extremity Solutions, LLC HRS Class II 2005-09-08
K051986 SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES Synthes (Usa) HRS Class II 2005-09-08
K052181 MODIFICATION TO XIA SPINAL SYSTEM Stryker Spine KWP Class II 2005-09-08
K051407 LEGEND ALL-POLY CUP Ortho Development Corp. JDI Class II 2005-09-08
K052098 CONNEXUS, .5CC, MODEL 023000-005 Isotis Orthobiologics, Inc. MQV Class II 2005-09-07
K051716 VERTEBRON PSS PEDICLE SCREW SYSTEM Vertebron, Inc. KWP Class II 2005-09-07
K050388 REFIX INTERNAL FRACTURE FIXATION SCREWS Xtremi-T, LLC HWC Class II 2005-09-07
K051820 PARALLAX EZFLOW CEMENT DELIVERY SYSTEM Arthrocare Corp. OAR Class I 2005-09-06
K051740 TAPERED COMPRESSION PIN Nexa Orthopedics, Inc. JDW Class II 2005-09-06
K052237 SC CERAMIC BALL HEADS Orthopedic Alliance, LLC LZO Class II 2005-09-06
K051616 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES Vanguard Medical Concepts, Inc. KTT Class II 2005-09-06
K051747 SBI WRISTFIT Small Bone Innovations, LLC HRS Class II 2005-09-06
K052005 R&R EXTERNAL FIXATION SYSTEM R&R Medical, Inc. KTT Class II 2005-09-06
K051975 POROUS COATED DISCOVERY ELBOW Biomet, Inc. JDC Class II 2005-09-06
K051556 ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE Exactech, Inc. LPH Class II 2005-09-06
K051611 MBARESORB IMPLANT Kinetikos Medical, Inc. HWC Class II 2005-09-06
K051945 MIOT PLATING SYSTEM Orthofix Srl HRS Class II 2005-09-06
K051775 OSTEOMIMETIC SYNTHETIC BONE MATRIX Biomimetic Pharmaceuticals, Inc. MQV Class II 2005-09-06
K052144 TSRH SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2005-08-31
K052086 ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER Encore Medical, Inc. PHX Class II 2005-08-31
K050468 TRIABSORB COMPOSITE SCREW Advanced Biomaterials HWC Class II 2005-08-31
K051380 TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM Howmedica Osteonics Corp. MBH Class II 2005-08-30
K052072 THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES Abbott Spine, Inc. KWQ Class II 2005-08-29
K050269 U1 HIP SYSTEM - BIPOLAR United Orthopedic Corp. KWY Class II 2005-08-29
K051296 SIJF CANNULATED SCREW SYSTEM Depuy Spine, Inc. OUR Class II 2005-08-26
K052064 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES Alliance Medical Corp. KTT Class II 2005-08-25
K052062 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES Alliance Medical Corp. KTT Class II 2005-08-25
K052080 MATRYX INTERFERENCE SCREW Linvatec Biomaterials, Inc. HWC Class II 2005-08-25
K050764 UNIGLIDE UNICONDYLAR KNEE PROSTHESIS Corin USA HRY Class II 2005-08-24
K051567 APTUS TITANIUM OSTEOSYNTHESIS SYSTEM Medartis, Inc. HRS Class II 2005-08-23
K052180 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek KWP Class II 2005-08-23
K052058 MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL Fournitures Hospitalieres Industrie HSB Class II 2005-08-22
K051642 FR.O.H. CALCANEUS REPAIR SYSTEM I.T.S. Implantat-Technologie-Systeme GmbH NDF Class II 2005-08-22
K051995 PROFEMUR RENAISSANCE HIP STEM Wrightmedicaltechnologyinc JDL Class III 2005-08-22
K052065 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES Alliance Medical Corp. KTT Class II 2005-08-22
K052187 MODIFICATION TO: CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2005-08-22
K051348 CONSERVE TOTAL FEMORAL HEAD Wrightmedicaltechnologyinc JDL Class III 2005-08-19
K051973 MODIFICATION TO: XIA STAINLESS STEEL SYSTEM Stryker Spine KWP Class II 2005-08-18
K052069 PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES Globus Medical, Inc. KWP Class II 2005-08-17
K050222 VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS Biomet, Inc. MBH Class II 2005-08-16
K052096 NUBIC SPINAL IMPLANT Signus Medical, LLC MQP Class II 2005-08-16
K052054 TSRH SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2005-08-16
K051615 STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES Regeneration Technologies, Inc. MQV Class II 2005-08-15
K050262 U2 ACETABULAR COMPONENT United Orthopedic Corp. LWJ Class II 2005-08-15
K051827 JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE Joimax GmbH HRX Class II 2005-08-12
K051908 CHARLOTTE COMPRESSION PLATE Wrightmedicaltechnologyinc HRS Class II 2005-08-10
K051605 SBI K-WIRES Small Bone Innovations, LLC HTY Class II 2005-08-10
K052011 PILONPLATE WITH ANGULAR STABILITY I.T.S. Implantat-Technologie-Systeme GmbH HRS Class II 2005-08-10
K051479 RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS Biomet Manufacturing, Inc. KRO Class II 2005-08-10
K050657 MONDEAL CONTOUR HO SYSTEM Kapp Surgical Instrument, Inc. HRS Class II 2005-08-08
K050655 MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 Kapp Surgical Instrument, Inc. HRS Class II 2005-08-08
K051884 CHARLOTTE SMALL MTP FUSION PLATE Wrightmedicaltechnologyinc HRS Class II 2005-08-05
K051385 EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE Biomet, Inc. KWI Class II 2005-08-05
K043547 COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM Biomet, Inc. KWA Class III 2005-08-05
K051983 MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR Axya Medical, Inc. MAI Class II 2005-08-05
K051570 AVL HINGE KNEE SYSTEM Biomet, Inc. KRO Class II 2005-08-05
K052037 MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM Howmedica Osteonics Corp. KTT Class II 2005-08-05
K040627 DEPUY ASR MODULAR ACETABULAR CUP SYSTEM DePuy Orthopaedics, Inc. KWA Class III 2005-08-05
K051989 GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE Depuy Mitek, A Johnson & Johnson Company JDR Class II 2005-08-05
K051496 COBALT BONE CEMENT Biomet, Inc. LOD Class II 2005-08-04
K051362 INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000 Inion OY MAI Class II 2005-08-04
K051971 OPTIMA SPINAL SYSTEM U&I Corp. KWQ Class II 2005-08-04
K051532 COBALT G HV BONE CEMENT Biomet, Inc. LOD Class II 2005-08-03
K051406 OSTEOCURE RESORBABLE BEAD KIT Nexa Orthopedics, Inc. MQV Class II 2005-08-01
K051590 T2 ANKLE ARTHRODESIS NAIL Howmedica Osteonics Corp. HSB Class II 2005-07-29
K042125 AFT Musculoskeletal Transplant Foundation MQV Class II 2005-07-28
K051454 ALEUTIAN SPACER SYSTEM K2m, LLC MQP Class II 2005-07-27
K051756 MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ Zimmer Trabecular JWH Class II 2005-07-27
K051942 MALIBU SPINAL SYSTEM Seaspine, Inc. KWP Class II 2005-07-27
K050979 S4 SPINAL SYSTEM Aesculap, Inc. MNI Class II 2005-07-27
K050461 XIA 4.5 SPINAL SYSTEM Stryker Spine MNH Class II 2005-07-27
K050681 OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES TriMed, Inc. HRS Class II 2005-07-27
K051600 SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM Synthes (Usa) KTT Class II 2005-07-27
K051516 TRABECULAR METAL REVISION SHELL LINERS Zimmer, Inc. JDI Class II 2005-07-27
K051310 PLC SCREW Smith & Nephew, Inc. HWC Class II 2005-07-26
K051180 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES Vanguard Medical Concepts, Inc. KTT Class II 2005-07-22
K051053 OSCAR, MODEL OE3000DB Orthosonics, Ltd. JDX Class II 2005-07-21
K051674 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2005-07-21
K051410 ACUMED RIB CONGRIENT BONE PLATE SYSTEM Acumed, LLC HRS Class II 2005-07-21
K050391 PROTEX CT CERVICOTHORACIC SPINAL SYSTEM Globus Medical, Inc. KWP Class II 2005-07-21
K051728 MODIFICATION TO SHOULDER FIXATION SYSTEM Hand Innovations, LLC LXT Class II 2005-07-20
K051229 PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT Smith & Nephew, Inc. JWH Class II 2005-07-20
K051738 SECUR-FIT MAX AND PLUS MAX HIP STEMS Howmedica Osteonics Corp. LZO Class II 2005-07-19
K051682 EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM Exactech, Inc. LZO Class II 2005-07-19
K051623 ANATOMICAL SHOULDER KEELED GLENOID Zimmer GmbH KWS Class II 2005-07-19
K051695 MARROW PLUS (M+) Berkeley Advanced Biomaterials, Inc. MQV Class II 2005-07-19
K051735 PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY Smith & Nephew, Inc. HRS Class II 2005-07-19
K050210 DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES Biomet, Inc. JWH Class II 2005-07-19
K051216 HYDRALOK SYSTEM Altiva Corp. MNH Class II 2005-07-19
K051162 GENEROS SB SMALL BONE DISTRACTION IMPLANT Orthonetx, Inc. KTT Class II 2005-07-19
K051737 MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE Howmedica Osteonics Corp. LZO Class II 2005-07-19
K043406 VERTEBROPLASTIC RADIOPAQUE BONE CEMENT Depuy Spine, Inc. NDN Class II 2005-07-15
K050848 TORNIER ELBOW PROSTHESIS Tornier JDB Class II 2005-07-14
K051764 T-PLATE ANTERIOR FIXATION SYSTEM Esm Technologies KWQ Class II 2005-07-13
K051049 SYNTHES (USA) LOW-PROFILE WRIST FIXATOR Synthes (Usa) KTT Class II 2005-07-13
K051659 SEMIAL SPINAL IMPLANT Signus Medizintechnik GmbH MQP Class II 2005-07-13

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