meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
36
Latest Decision
2006-02-27

Clearances · page 103 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K053182 DRLOCK DISTAL RADIUS VOLAR SYSTEM Orthohelix Surgical Designs, Inc. HRS Class II 2006-02-27
K060290 SHOULDER FIXATION SYSTEM Hand Innovations, LLC LXT Class II 2006-02-27
K060011 MIIG SR Wrightmedicaltechnologyinc MQV Class II 2006-02-27
K052241 DISC-FX SYSTEM Ellman International, Inc. HRX Class II 2006-02-24
K060350 CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM Blackstone Medical, Inc. MQP Class II 2006-02-24
K053344 BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR Smith & Nephew, Inc. HWC Class II 2006-02-23
K060017 MAKO SURGICAL UNICONDYLAR KNEE SYSTEM Mako Surgical Corp. HSX Class II 2006-02-23
K053561 BIO-MINI REVO SUTURE ANCHOR Conmed Linvatec HWC Class II 2006-02-23
K060253 STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST. Regeneration Technologies, Inc. HWC Class II 2006-02-23
K060283 TRANSET SYSTEM Bonutti Research, Inc. HTY Class II 2006-02-22
K052089 XR-SERIES BI-METRIC FEMORAL COMPONENTS Biomet Manufacturing, Inc. LPH Class II 2006-02-17
K051525 ARX SPINAL SYSTEM Amedica Corp. MQP Class II 2006-02-17
K053581 NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM Nuvasive, Inc. KWQ Class II 2006-02-17
K053293 ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS Ortho Development Corp. LPH Class II 2006-02-16
K060131 OSS-BODIES PROXIMAL TIBIAL SLEEVE Biomet Manufacturing Corp KRO Class II 2006-02-15
K052321 VERSYS EPOCH FULLCOAT HIP PROSTHESIS Zimmer, Inc. LPH Class II 2006-02-15
K060081 BASIS SPINAL SYSTEM Medtronic Sofamor Danek KWP Class II 2006-02-13
K053070 CONTOUR II SPINAL SYSTEM Altiva Corp. MNH Class II 2006-02-13
K053508 SYNFIX-LR Synthes Spine Co.Lp MQP Class II 2006-02-13
K060203 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2006-02-13
K050806 OPTECURE Exactech, Inc. MBP Class II 2006-02-08
K060041 TRIMED BONE PLATES TriMed, Inc. HRS Class II 2006-02-07
K053390 COLUMBUS (CR) TOTAL KNEE SYSTEM Aesculap, Inc. JWH Class II 2006-02-06
K053094 ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 Advanced Bio-Surfaces, Inc. HSH Class II 2006-02-06
K060107 MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS Exactech, Inc. LZO Class II 2006-02-06
K060152 MODIFICATION TO S4 SPINAL SYSTEM Aesculap, Inc. MNI Class II 2006-02-03
K052546 AEGIS ANTERIOR LUMBAR PLATE SYSTEM Depuy Spine, Inc. KWQ Class II 2006-02-03
K053461 EZLOC FEMORAL FIXATION DEVICE Arthrotek, Inc. MBI Class II 2006-02-03
K060031 DEPUY MODULAR M HEADS DePuy Orthopaedics, Inc. LPH Class II 2006-01-31
K053228 THERIGRAFT TCP PUTTY BONE VOID FILLER Therics, LLC MQV Class II 2006-01-31
K052915 PROFEMUR XTR HIP STEM Wrightmedicaltechnologyinc KWA Class III 2006-01-27
K052918 REPROCESSED EXTERNAL FIXATION DEVICES Alliance Medical Corp. KTT Class II 2006-01-27
K060026 KOBY SURGICAL INTERNAL FIXATION SYSTEM Koby Surgical HWC Class II 2006-01-26
K060071 NEXA COMPRESSION SCREW Nexa Orthopedics, Inc. HWC Class II 2006-01-26
K053642 OSTEOSET DBM PELLETS Wrightmedicaltechnologyinc MBP Class II 2006-01-26
K053514 TRIATHLON TOTAL KNEE SYSTEM Stryker Orthopaedics JWH Class II 2006-01-26
K053198 SIMPLEX P SPEEDSET BONE CEMENT Howmedica Osteonics Corp. LOD Class II 2006-01-26
K053338 ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS Arthrex, Inc. HWC Class II 2006-01-26
K052812 OSSIMEND (TM) BONE GRAFT MATERIAL Collagen Matrix, Inc. MQV Class II 2006-01-25
K053274 ANATOMICAL SHOULDER INVERSE/REVERSE Zimmer GmbH PHX Class II 2006-01-25
K053180 PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS Arthrocare Corp. NDN Class II 2006-01-25
K053557 ESKA-LIBUR HIP STEM Eska Implants GmbH & Co. LPH Class II 2006-01-20
K051774 MBCP Biomatlante MQV Class II 2006-01-20
K053292 DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS Scient'X USA, Inc. MQP Class II 2006-01-19
K053528 SHORT CITATION FEMORAL STEM Stryker Orthopaedics MEH Class II 2006-01-13
K053267 ENDIUS ATAVI SYSTEM Endius, Inc. HRX Class II 2006-01-13
K053513 T-PIN Union Surgical, LLC JDW Class II 2006-01-13
K042829 DBX STRIP Musculoskeletal Transplant Foundation MBP Class II 2006-01-13
K053588 PROFEMUR LX HIP STEM Wrightmedicaltechnologyinc KWA Class III 2006-01-13
K053472 HOFFMANN II MRI EXTERNAL FIXATION SYSTEM Howmedica Osteonics Corp. KTT Class II 2006-01-11
K053445 SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT DePuy Orthopaedics, Inc. LOD Class II 2006-01-06
K053474 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2006-01-06
K052566 NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY Abbott Spine, Inc. MNI Class II 2006-01-06
K053299 REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT Biomet Manufacturing, Inc. HRY Class II 2006-01-05
K053483 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek MNI Class II 2006-01-05
K053101 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2006-01-05
K053136 5TH METATARSAL FRACTURE SCREW Wrightmedicaltechnologyinc HWC Class II 2006-01-05
K051603 STRYKER INJECTABLE CEMENT Stryker Leibinger Micro Implants MQV Class II 2005-12-30
K052320 ENCORE CLP OFFSET TOTAL HIP SYSTEM Encore Medical Corporation KWA Class III 2005-12-30
K052735 ALLOCRAFT DBM Lifecell Corp. MBP Class II 2005-12-28
K053276 IST PEDICLE SCREW SYSTEM Innovative Spinal Technologies, Inc. NKB Class II 2005-12-27
K052265 SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL Smith & Nephew, Inc. NPJ Class II 2005-12-27
K052385 TANGORS POLYAXIAL SYSTEM Ulrich GmbH & Co. KG NKB Class II 2005-12-27
K052917 STRYKER COMPARTMENTAL KNEE SYSTEM Howmedica Osteonics Corp. NPJ Class II 2005-12-27
K052787 ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5) Exactech, Inc. LZO Class II 2005-12-27
K053051 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES Vanguard Medical Concepts, Inc. KTT Class II 2005-12-22
K053408 NEXA BONE PLATE AND SCREW SYSTEM Nexa Orthopedics, Inc. HRS Class II 2005-12-22
K052170 SEASPINE VBR SYSTEM Seaspine, Inc. MQP Class II 2005-12-21
K052810 SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM Scandius Biomedical, Inc. MBI Class II 2005-12-20
K052906 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM Zimmer, Inc. PHX Class II 2005-12-19
K052799 MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM Bonutti Research, Inc. MAI Class II 2005-12-16
K052990 STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM Biomet, Inc. KWY Class II 2005-12-16
K051781 GRAFTCAGE TLX Osteotech, Inc. MQP Class II 2005-12-16
K051195 GRAFTON DBM Osteotech, Inc. MBP Class II 2005-12-16
K051386 MASTERGRAFT PUTTY BONE VOID FILLER Medtronic Vascular MQV Class II 2005-12-16
K053394 NEXA BONE SCREW SYSTEM Nexa Orthopedics, Inc. HWC Class II 2005-12-14
K052776 TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD Arthrex, Inc. HTN Class II 2005-12-13
K052847 CAPLESS PEDICLE SCREW SYSTEM X-Spine Systems, Inc. MNI Class II 2005-12-12
K053261 ORTHOFIX TITANIUM NAILING SYSTEMS Orthofix Srl HSB Class II 2005-12-12
K052210 NUVASIVE COROENT EXTENSURE SYSTEM Nuvasive, Inc. MQP Class II 2005-12-12
K052901 ARTHREX TENSIONLOK Arthrex, Inc. HRS Class II 2005-12-12
K051275 LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM Allez Spine, LLC NKB Class II 2005-12-09
K053189 COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES Zimmer, Inc. JDC Class II 2005-12-09
K053349 HOFFMANN II ROD TO WIRE COUPLING Howmedica Osteonics Corp. KTT Class II 2005-12-09
K052398 MESA SPINAL SYSTEM K2m, LLC MNI Class II 2005-12-07
K052151 SYNTHES PANGEA MONOAXIAL SYSTEM Synthes Spine Co.Lp NKB Class II 2005-12-07
K052426 SMITH & NEPHEW MODULAR HIP Smith & Nephew, Inc. MEH Class II 2005-12-07
K053093 KALIX II IMPLANT, MODEL 141 0XX WITH XX New Deal, S.A. HWC Class II 2005-12-07
K052275 SMITH & NEPHEW PLATFORM HIP STEM Smith & Nephew, Inc. LZO Class II 2005-12-07
K053119 DISTAL RADIO-ULNAR JOINT IMPLANT Aptis Medical, LLC KXE Class II 2005-12-07
K052888 POROUS TITANIUM ACETABULAR AUGMENTS Biomet Manufacturing Corp KWA Class III 2005-12-06
K053115 XIA SPINAL SYSTEM Stryker Spine MNI Class II 2005-12-06
K043209 VIAGRAF DBM PASTE Osteotech, Inc. MBP Class II 2005-12-05
K052683 SYNTHES (USA) STERNAL FIXATION SYSTEM Synthes (Usa) HRS Class II 2005-12-05
K052026 LINEAGE A-CLASS POLY LINER Wrightmedicaltechnologyinc LPH Class II 2005-12-05
K050642 ORTHOBLAST II PUTTY AND PASTE Isotis Orthobiologics, Inc. MBP Class II 2005-12-05
K052572 ANSPACH KNOTLESS ANCHOR The Anspach Effort, Inc. MBI Class II 2005-12-05
K053105 SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP Synthes (Usa) HSB Class II 2005-12-02
K052748 SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS Howmedica Osteonics Corp. JDI Class II 2005-12-02
K053080 GRAFTCAGE ACX Osteotech, Inc. MQP Class II 2005-12-01

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