meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
33
Latest Decision
2005-04-15

Clearances · page 107 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K050101 THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 Zimmer Trabecular HRS Class II 2005-04-15
K050607 SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO) Synthes (Usa) HRS Class II 2005-04-11
K050675 EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE Depuy Spine, Inc. MNI Class II 2005-04-11
K042565 ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER Ortho Development Corp. LPH Class II 2005-04-11
K050774 LANX ANTERIOR CERVICAL PLATE SYSTEM Lanx, LLC KWQ Class II 2005-04-11
K050804 MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM Aesculap, Inc. KWQ Class II 2005-04-11
K050819 CHARLOTTE SNAP-OFF SCREW Wrightmedicaltechnologyinc HWC Class II 2005-04-11
K050666 GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES Berkeley Advanced Biomaterials, Inc. MQV Class II 2005-04-11
K050761 ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM Zimmer, Inc. KWT Class II 2005-04-11
K043053 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek KWP Class II 2005-04-11
K050490 OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER Medicrea MQV Class II 2005-04-11
K050631 SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION Synthes (Usa) LXT Class II 2005-04-11
K050624 STRYKER SPINE AVS PL PEEK SPACER Stryker Spine MQP Class II 2005-04-11
K050539 SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT Howmedica Osteonics Corp. JWH Class II 2005-03-29
K050416 OSSAPLAST ORTHO Ossacur AG MQV Class II 2005-03-29
K042091 BIOLOX DELTA CERAMIC HEADS Biomet, Inc. LZO Class II 2005-03-25
K040419 DYNAGRAFT II Isotis Orthobiologics, Inc. MQV Class II 2005-03-25
K050497 BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET Linvatec Corp. HWC Class II 2005-03-25
K050028 MAESTRO CARPAL HEMIARTHROPLASTY Biomet Manufacturing, Inc. KWN Class II 2005-03-25
K041066 ENCORE REVERSE SHOULDER PROSTHESIS Encore Medical L.P. PHX Class II 2005-03-24
K050451 SYNTHES VECTRA SYSTEM Synthes Spine Co.Lp KWQ Class II 2005-03-24
K050439 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. NKB Class II 2005-03-24
K050634 MODIFICATION TO: ARTHREX V-TAK Arthrex, Inc. HWC Class II 2005-03-21
K050138 MODIFICATION TO: RESTORATION MODULAR SYSTEM Howmedica Osteonics Corp. JDI Class II 2005-03-21
K050512 STRYKER LOCKED PLATING SYSTEM Howmedica Osteonics Corp. HRS Class II 2005-03-21
K043488 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2005-03-21
K050346 STABILIZATION SCREW New Deal, S.A. HWC Class II 2005-03-17
K040262 DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX Musculoskeletal Transplant Foundation MQV Class II 2005-03-17
K042899 SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS Synthes (Usa) HTO Class I 2005-03-16
K050316 AEQUALIS REVERSED SHOULDER PROSTHESIS Tornier PHX Class II 2005-03-16
K042344 EXCIA TOTAL HIP SYSTEM Aesculap, Inc. LWJ Class II 2005-03-16
K050241 AOS HUMERAL NAIL Advanced Orthopaedic Solutions, Inc. HSB Class II 2005-03-14
K042515 SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE Smith & Nephew, Inc. JWH Class II 2005-03-14
K050492 INTEGRA BONE FIXATION SYSTEM Integra Lifesciences Corp. HRS Class II 2005-03-14
K050457 MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM Merete Medical GmbH KTT Class II 2005-03-14
K043058 PINNACLE CONSTRAINED ACETABULAR LINERS Depuy, Inc. KWZ Class II 2005-03-14
K050390 TAMARACK ANTERIOR THORACOLUNBAR Alphatec/Nexmed KWQ Class II 2005-03-14
K043570 UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD Conformis, Inc. HSX Class II 2005-03-14
K043565 MODIFICATION TO DYNESYS SPINAL SYSTEM Zimmer Spine, Inc. NQP Class II 2005-03-11
K041825 SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT Smith & Nephew, Inc. JWH Class II 2005-03-11
K043526 SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC Noble Fiber Technologies, Inc. LGF Class I 2005-03-10
K042051 ARCOMXL POLYETHYLENE LINERS Biomet, Inc. LPH Class II 2005-03-08
K043101 NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS Zimmer, Inc. JWH Class II 2005-03-07
K043578 THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM Solco Biomedical Co., Ltd. MNH Class II 2005-03-07
K050275 MODIFICATION TO: INION OTPS BIODEGRADABLE PIN Inion , Ltd. HTY Class II 2005-03-07
K050110 SYNTHES (USA) LCP MODULAR FOOT PLATES Synthes (Usa) HRS Class II 2005-03-04
K050048 HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM Howmedica Osteonics Corp. KTT Class II 2005-03-04
K050227 THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER Linvatec Corp. MBI Class II 2005-03-02
K043180 STRYKER SPINE TRIO PS Stryker Spine MNH Class II 2005-03-02
K050041 SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM Synthes (Usa) JDQ Class II 2005-02-25
K043410 EPIPHYSIS SCREW I.T.S. Implantat-Technologie-Systeme GmbH HWC Class II 2005-02-24
K042600 STANSION MATRIX Spineworks, LLC MQP Class II 2005-02-18
K043440 SMITH & NEPHEW, INC. REVISION KNEE SYSTEM Smith & Nephew, Inc. JWH Class II 2005-02-18
K043145 BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B Arthrex, Inc. HTN Class II 2005-02-18
K043142 INION OTPS BIODEGRADABLE MINI PLATING SYSTEM Inion , Ltd. HWC Class II 2005-02-18
K031399 INTERGRO DBM Interpore Cross Intl. MQV Class II 2005-02-18
K050282 MODIFICATION TO TSRH SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2005-02-18
K050078 ROC LUMBAR PLATING SYSTEM Alphatec/Nexmed MNH Class II 2005-02-18
K043338 BLAKSTONE LAMINOPLASTY FIXATION SYSTEM Blackstone Medical, Inc. NQW Class II 2005-02-18
K043411 RESOFIX BIOABSORBABLE EXPANSION BOLT Resofix, Inc. HTN Class II 2005-02-17
K050117 MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM Medtronic Sofamor Danek KWQ Class II 2005-02-17
K042928 MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM U&I Corp. MNH Class II 2005-02-17
K043100 BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS Biomet, Inc. MBF Class II 2005-02-17
K043421 OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC Regeneration Technologies, Inc. MQV Class II 2005-02-16
K043374 DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING Howmedica Osteonics Corp. MBH Class II 2005-02-16
K043308 MODIFICATION TO: HEALOS BONE GRAFT MATERIAL Depuy Spine, Inc. MQV Class II 2005-02-16
K050189 TECHTONIX SYSTEM Stryker Spine KWP Class II 2005-02-16
K043248 TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS Arthrex, Inc. HTN Class II 2005-02-16
K043431 GAMMA3 NAIL SYSTEM Howmedica Osteonics Corp. HSB Class II 2005-02-16
K050118 EBI TROCHANTERIC NAIL SYSTEM Ebi, L.P. HSB Class II 2005-02-16
K042992 CORAIL AMT HIP PROSTHESIS DePuy Orthopaedics, Inc. LZO Class II 2005-02-11
K050226 ASIAN INTRAMEDULLARY HIP SCREW NAILS Smith & Nephew, Inc. HWC Class II 2005-02-11
K042757 VANGUARD SSK KNEE SYSTEM Biomet, Inc. JWH Class II 2005-02-11
K041940 HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS Howmedica Osteonics Corp. LZO Class II 2005-02-11
K043289 E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT Signal Medical Corp. KTT Class II 2005-02-11
K043094 EASYSPINE SYSTEM Ldr Spine USA MNI Class II 2005-02-11
K042571 STRYKER SPINE AVS TL PEEK SPACER Stryker Spine MQP Class II 2005-02-11
K043420 OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE Regeneration Technologies, Inc. MQV Class II 2005-02-10
K033716 TRIDENT ACETABULAR SYSTEM Howmedica Osteonics Corp. LPH Class II 2005-02-10
K050079 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. KWP Class II 2005-02-10
K043123 APEX MODULAR HA HIP STEM Apex Surgical, LLC LPH Class II 2005-02-10
K042343 SCORPIO NRG KNEE SYSTEM Howmedica Osteonics Corp. JWH Class II 2005-02-09
K043505 DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM Biomet, Inc. KWT Class II 2005-02-09
K041798 ATALIA TITANIUM SURGICAL MESH Us Spinal Technologies, LLC MQP Class II 2005-02-07
K042073 OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM Olsen Medical KWQ Class II 2005-02-07
K043316 RABEA SPINAL IMPLANT Signus Medizintechnik GmbH MQP Class II 2005-02-07
K043174 STEALTH FUSION SYSTEM, MODEL RR 1000 R&R Medical, Inc. KTT Class II 2005-02-07
K043405 NUVASIVE COROENT SYSTEM Nuvasive, Inc. MQP Class II 2005-02-07
K043321 MODIFICATION TO: CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2005-02-03
K043185 SYNTHES 3.5MM CORTEX SCREWS Synthes (Usa) HWC Class II 2005-02-03
K043066 PIONEER ANTERIOR CERVICAL PLATE SYSTEM Pioneer Surgical Technology KWQ Class II 2005-02-03
K050025 NANOSS BONE VOID FILLER Angstrom Medica, Inc. MQV Class II 2005-02-03
K043200 SIGN FIN NAIL Surgical Implant Generation Network (Sign) HSB Class II 2005-02-03
K043152 VERTEBRON PSS PEDICLE SCREW SYSTEM Vertebron, Inc. MNH Class II 2005-02-01
K031782 GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS Medtronic Sofamor Danek KWQ Class II 2005-02-01
K043151 MODIFICATION TO: CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek KWQ Class II 2005-02-01
K043233 GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL Efratgo, Ltd. HI Tech Bio-Surgical HSB Class II 2005-02-01
K043346 GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00 Genesis Medical LLC KWS Class II 2005-01-31
K050121 ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359 Zimmer, Inc. HRS Class II 2005-01-31
K043270 SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES Zimmer GmbH HSB Class II 2005-01-31

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