meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
35
Latest Decision
2007-01-18

Clearances · page 99 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K063732 MICROPLASTY TIBIAL TRAYS Biomet Manufacturing Corp JWH Class II 2007-01-18
K063211 PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT Stelkast Company JWH Class II 2007-01-18
K063438 VSPSPN Tecres S.P.A. NDN Class II 2007-01-17
K063741 EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2007-01-17
K062775 EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM Ortho Development Corp. LPH Class II 2007-01-16
K062181 C-JAWS CERVICAL COMPRESSIVE MINI FRAME Medicrea Technologies KWP Class II 2007-01-16
K062978 U2 HIP STEM, TI PLASMA SPRAY United Orthopedic Corp. LWJ Class II 2007-01-16
K063278 PORTLAND COBALT CHROME FEMORAL HEAD Portland Orthopaedics Limited JDI Class II 2007-01-12
K062670 VERTIFLEX SPINAL SCREW SYSTEM Vertiflex (Tm), Incorporated MNH Class II 2007-01-12
K063370 CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY Arthrosurface, Inc. KWD Class II 2007-01-12
K062759 PARAMOUNT VBR SYSTEM Innovative Spinal Technologies, Inc. MQP Class II 2007-01-12
K063406 ENCORE KNEE SYSTEM IFU Encore Medical L.P. JWH Class II 2007-01-08
K062553 SIMPLEX P BONE CEMENT Stryker Orthopaedics LOD Class II 2007-01-08
K063509 DEPUY PEAK FX HIP PLATE DePuy Orthopaedics, Inc. KTT Class II 2007-01-04
K063709 TS-BONE HIP TOOL Orthopedic Sciences, Inc. HRS Class II 2007-01-04
K063058 ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS Arthrex, Inc. KWD Class II 2007-01-03
K053218 DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX Musculoskeletal Transplant Foundation MQV Class II 2006-12-28
K063225 METAIZEAU NAILING SYSTEM Howmedica Osteonics Corp. HSB Class II 2006-12-27
K063244 ARC SURGICAL BONE REDUCTION SCREW Arc Surgical, LLC HWC Class II 2006-12-27
K063009 FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES) Praesidia S.R.L. HRS Class II 2006-12-27
K063017 AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM Aesculap, Inc. JDQ Class II 2006-12-27
K062785 LTD POLYAXIAL FIXATION SYSTEM Us Spine KWP Class II 2006-12-26
K061578 SSP VERTEBRAL BODY REPLACEMENT Specialty Spine Products, LLC MQP Class II 2006-12-26
K060416 OBELISC VERTEBRAL BODY REPLACEMENT DEVICE Ulrich GmbH & Co. KG MQP Class II 2006-12-26
K063166 I.T.S. PELVIC RECONSTRUCTION SYSTEM I.T.S. Implantat-Technologie-Systeme GmbH HRS Class II 2006-12-22
K062513 APEX SPINE SYSTEM Spinecraft, Inc. KWP Class II 2006-12-22
K063095 HUMERUS LOCKING PLATING SYSTEM Newclip Technics HRS Class II 2006-12-22
K063551 AEQUALIS HUMERAL PLATE Tornier KTT Class II 2006-12-22
K062879 TRAVERSE OCT SPINAL FIXATION SYSTEM Medtronic Sofamor Danek, Inc. MNI Class II 2006-12-22
K062661 AEQUALIS RESURFACING HEAD Tornier HSD Class II 2006-12-22
K062151 BOX PEEK VBR SYSTEM Innovasis, Inc. MQP Class II 2006-12-22
K062383 UNISYN HA PLASMA MODULAR HIP Hayes Medical, Inc. LWJ Class II 2006-12-21
K062353 MOZAIK BONE REGENERATION MATRIX - PUTTY Integra LifeSciences Corporation MQV Class II 2006-12-20
K061461 MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05 Zimmer, Inc. LPH Class II 2006-12-20
K063616 TRIDENT II ACETABULAR SYSTEM Howmedica Osteonics Corp. LZO Class II 2006-12-20
K063499 MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM Scandius Biomedical, Inc. MBI Class II 2006-12-19
K062038 X-STEN MILD TOOL KIT, MODEL MTK-0001 X-Sten Corp. HRX Class II 2006-12-19
K063497 MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM Scandius Biomedical, Inc. MAI Class II 2006-12-19
K062836 CITADEL ANTERIOR LUMBAR PLATE SYSTEM Globus Medical, Inc. KWQ Class II 2006-12-19
K060794 PROGENIX DBM PUTTY AND PASTE Medtronic Sofamor Danek MBP Class II 2006-12-18
K061082 MOBIS SPINAL IMPLANT Signus Medizintechnik GmbH MQP Class II 2006-12-18
K063049 SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM Synthes (Usa) HRS Class II 2006-12-18
K063506 LORENZ STERNAL CLOSURE SYSTEM Walter Lorenz Surgical, Inc. HRS Class II 2006-12-18
K061462 BF+ (PH) Ldr Spine USA MQV Class II 2006-12-15
K062426 DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS DePuy Orthopaedics, Inc. KWA Class III 2006-12-15
K063478 VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810) Depuy Mitek, A Johnson & Johnson Company HWC Class II 2006-12-15
K063070 APERFIX TIBIAL IMPLANT WITH INSERTER Cayenne Medical, Inc. HWC Class II 2006-12-14
K063020 INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM Intai Technology, Inc. HRS Class II 2006-12-14
K062380 FLOSIMPLE ARTHROSCOPY PUMP A120 W.O.M. World of Medicine AG HRX Class II 2006-12-14
K061774 NFIX II PEDICLE SCREW SYSTEM N Spine, Inc. NQP Class II 2006-12-13
K063479 ARTHREX PUSHLOCK Arthrex, Inc. HWC Class II 2006-12-13
K062845 MODULAR REPLACEMENT ELBOW SYSTEM Howmedica Osteonics Corp. HSD Class II 2006-12-13
K063414 MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 Encore Medical L.P. KWA Class III 2006-12-12
K063428 XIA STAINLESS STEEL SPINAL SYSTEM Stryker Spine NKB Class II 2006-12-11
K060694 MODULAR HYBRID GLENOID Biomet Manufacturing Corp KWS Class II 2006-12-11
K062997 ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS Biomet Manufacturing Corp LZO Class II 2006-12-08
K063460 ACUMED CONGRUENT BONE PLATE SYSTEM Acumed, LLC HRS Class II 2006-12-07
K061844 DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER Wrightmedicaltechnologyinc JDL Class III 2006-12-06
K060988 TOTAL AND HEMI SHOULDER SYSTEM Dvo Extremity Solutions, LLC KWS Class II 2006-12-06
K062371 PREVIEW ANTERIOR CERVICAL PLATE SYSTEM Alphaspine, Inc. KWQ Class II 2006-12-04
K062960 CONSERVE FEMORAL RESURFACING COMPONENT Wrightmedicaltechnologyinc KXA Class II 2006-12-01
K062748 MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD DePuy Orthopaedics, Inc. LZO Class II 2006-11-30
K062466 ARTHREX INTERFERENCE SCREW Arthrex, Inc. MAI Class II 2006-11-29
K063279 NOVATION SPLINED RDD FEMORAL STEMS Exactech, Inc. LZO Class II 2006-11-29
K063257 FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT Encore Medical L.P. LPH Class II 2006-11-22
K063156 MODIFICATION TO EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2006-11-22
K062270 RADIUS SPINAL SYSTEM Stryker Spine NKB Class II 2006-11-22
K062684 EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD Aesculap, Inc. LZO Class II 2006-11-22
K063303 UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS Zimmer, Inc. HRS Class II 2006-11-22
K061749 ECLIPSE TOTAL ANKLE IMPLANT Kinetikos Medical, Inc. HSN Class II 2006-11-22
K062980 ACTIVASCREW Bioretec, Ltd. HWC Class II 2006-11-22
K063273 PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR Depuy Miltek, A Johnson & Johnson Co. JDR Class II 2006-11-22
K062734 ADJUST-RIGHT FIXATION DEVICES Valpo Orthopedic Technology, Inc. JDR Class II 2006-11-22
K062487 APERFIX FEMORAL IMPLANT WITH INSERTER Cayenne Medical, Inc. HWC Class II 2006-11-17
K062643 KINETIC ANTERIOR CERVICAL PLATE Life Spine KWQ Class II 2006-11-16
K062934 SIERRA Seaspine, Inc. MNI Class II 2006-11-16
K061002 MAXIMA ANTERIOR CERVICAL PLATE SYSTEM U&I Corp. KWQ Class II 2006-11-15
K062419 TRIDENT LARGE DIAMETER ACETABULAR INSERTS Howmedica Osteonics Corp. LPH Class II 2006-11-15
K063158 SYNTHES ANTEGRA SYSTEM Synthes Spine Co.Lp KWQ Class II 2006-11-14
K062908 ORTHROPRO HEMI TOE Orthopro, LLC KWD Class II 2006-11-13
K062898 SBI LATERAL RHEAD IMPLANT Small Bone Innovations, Inc. KWI Class II 2006-11-13
K062920 ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP Orthofix Srl KTW Class II 2006-11-13
K060544 SALTO TALARIS TOTAL ANKLE PROSTHESIS Tornier HSN Class II 2006-11-13
K062782 INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001 Inion OY MAI Class II 2006-11-09
K063081 AEQUALIS SHOULDER SYSTEM Tornier HSD Class II 2006-11-09
K063083 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. NKB Class II 2006-11-06
K062807 TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. NKB Class II 2006-11-06
K063067 CONFIDENCE FENESTRATED INTRODUCER NEEDLE Disc-O-Tech Medical Technologies, Ltd. NDN Class II 2006-11-03
K062174 MODIFICATION TO EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. MNH Class II 2006-11-02
K063033 MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT Orthopedic Sciences, Inc. HRS Class II 2006-11-01
K061925 MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS Arthrex, Inc. HTN Class II 2006-10-31
K062995 M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT Biomet Manufacturing Corp KWA Class III 2006-10-31
K063002 ALTRA PRESS-FIT HIP SYSTEM Biomet Manufacturing Corp KWA Class III 2006-10-31
K062861 ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM Ascension Orthopedics, Inc. HSD Class II 2006-10-31
K062029 ANATOMICAL SHOULDER FRACTURE SYSTEM Zimmer GmbH KWS Class II 2006-10-31
K062863 OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM Osteomed LP HWC Class II 2006-10-31
K062498 PROFYLE SYSTEM Howmedica Osteonics Corp. HRS Class II 2006-10-25
K061342 MALIBU SPINAL SYSTEM Seaspine, Inc. NKB Class II 2006-10-25
K060615 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2006-10-25
K062103 DARCO FORCE TITANIUM COMPRESSION SCREW Darco International, Inc. HWC Class II 2006-10-25

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