meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
28
Latest Decision
2004-11-09

Clearances · page 109 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K041075 FASTIN RC ANCHOR Depuy Mitek, A Johnson & Johnson Company HWC Class II 2004-11-09
K041170 SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS Howmedica Osteonics Corp. LZO Class II 2004-11-09
K042842 NOVATION 12/14 PRESS-FIT FEMORAL STEM Exactech, Inc. LZO Class II 2004-11-09
K042029 X-SERIES INTEGRAL RPP FEMORAL COMPONENTS Biomet, Inc. LPH Class II 2004-11-09
K042796 ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE Coapt Systems, Inc. HWC Class II 2004-11-05
K042790 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2004-11-04
K042210 MSD SILO SPINAL SYSTEM Medtronic Sofamor Danek MNI Class II 2004-11-04
K040354 METAL/METAL HIP SYSTEM Encore Medical L.P. KWA Class III 2004-11-04
K042798 C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM Interpore Cross Intl. KWQ Class II 2004-11-04
K042337 ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING Zimmer, Inc. LPH Class II 2004-11-04
K042776 VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX Zimmer, Inc. LPH Class II 2004-11-04
K041356 ARTHREX TENODESIS SCREW FAMILY Arthrex, Inc. HWC Class II 2004-11-04
K042778 BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE Linvatec Corp. HWC Class II 2004-11-04
K041189 ARTHREX TRIMIT FAMILY Arthrex, Inc. HWC Class II 2004-11-04
K042093 VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS Biomet, Inc. HRY Class II 2004-11-01
K042598 PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES Zimmer, Inc. HRS Class II 2004-10-29
K042460 TI - SCREW ANCHOR SP Arthrotek, Inc. MBI Class II 2004-10-29
K041100 NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS Zimmer, Inc. MBH Class II 2004-10-29
K042695 NCB PLATING SYSTEM Zimmer GmbH HRS Class II 2004-10-29
K042268 EBI CAS SPINE SPACER SYSTEM Ebi, L.P. MQP Class II 2004-10-27
K042355 SYNTHES (USA) LCP WRIST FUSION PLATES Synthes (Usa) HRS Class II 2004-10-27
K042673 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM Alphatec/Nexmed KWP Class II 2004-10-27
K042021 EXACTECH EQUINOXE SHOULDER SYSTEM Exactech, Inc. KWS Class II 2004-10-26
K042591 SMARTMIX PRE-FILLED MIXING SYSTEM DePuy Orthopaedics, Inc. KIH Class I 2004-10-22
K042305 OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903 Ossacur AG MQV Class II 2004-10-21
K041988 ARTHROTEK MENISCAL HYBRID DEVICE Biomet, Inc. JDR Class II 2004-10-20
K041961 SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM Scandius Biomedical, Inc. HWC Class II 2004-10-20
K033943 ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED Centerpulse Orthopedics, Inc. KWA Class III 2004-10-18
K042271 NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES Zimmer, Inc. JWH Class II 2004-10-13
K042396 T2 PROXIMAL HUMERAL NAIL Howmedica Osteonics Corp. HSB Class II 2004-10-08
K042524 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek KWP Class II 2004-10-08
K041353 FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM Jri Manufacturing, Ltd. MEH Class II 2004-10-08
K042437 DORSAL INTRAMEDULLARY PLATE Deo Volente Orthopaedics, LLC HRS Class II 2004-10-08
K042508 SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM Depuy Spine, Inc. KWP Class II 2004-10-07
K042135 SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION) Synthes (Usa) HSB Class II 2004-10-07
K042143 EXCELLA-M SPINAL SYSTEM Innovasis, Inc. KWP Class II 2004-10-07
K042499 ORION ANTERIOR CERVICAL PLATING SYSTEM Medtronic Sofamor Danek KWQ Class II 2004-10-07
K042358 LOCON VLS DISTAL RADIUS PLATE SYSTEM Wrightmedicaltechnologyinc KTT Class II 2004-10-07
K042498 VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek KWP Class II 2004-10-07
K042201 NOVEL VBR SPINAL SYSTEM Alphatec/Nexmed MQP Class II 2004-10-07
K042453 MODIFICATION TO EQUATION FIXATION SYSTEM Medtronic Sofamor Danek, Inc. MNI Class II 2004-10-07
K042356 SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS Synthes (Usa) HWC Class II 2004-10-07
K042377 SYNTHES LOW PROFILE RECONSTRUCTION PLATES Synthes (Usa) HRS Class II 2004-10-07
K042032 MAESTRO TOTAL WRIST Biomet, Inc. JWJ Class II 2004-10-07
K042332 TITANIUM TELEGRAPH HUMERAL NAIL Fournitures Hospitalieres Industrie HSB Class II 2004-10-07
K042436 IIIZAROV PULLEY SYSTEM Smith & Nephew, Inc. KTT Class II 2004-10-07
K042440 ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM Alphatec/Nexmed HSB Class II 2004-10-07
K042514 MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM Blackstone Medical, Inc. MNI Class II 2004-10-07
K042458 A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM A.M. Surgical, Inc. LXT Class II 2004-10-07
K041858 ACUMED ANATOMIC RADIAL HEAD SYSTEM Acumed, LLC KWI Class II 2004-10-05
K041698 AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR Axya Medical, Inc. MAI Class II 2004-10-05
K040601 EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS Exactech, Inc. KWZ Class II 2004-10-04
K040889 EXACTECH OPTETRAK UNICONDYLAR KNEE Exactech, Inc. HRY Class II 2004-10-01
K041389 SYNTHES CONTOURED SYNMESH SPACER Synthes Spine MQP Class II 2004-10-01
K042402 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek, Inc. KWP Class II 2004-10-01
K041808 ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM Endius, Inc. KWP Class II 2004-10-01
K042037 M2A MAGNUM SYSTEM Biomet, Inc. KWA Class III 2004-10-01
K042059 SHOULDER FIXATION SYSTEM Hand Innovations, Inc. LXT Class II 2004-09-30
K040630 TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ Implex Corp. JWH Class II 2004-09-30
K041835 ENDOTINE MIDFACE B 4.5 DEVICE Coapt Systems, Inc. HWC Class II 2004-09-28
K041925 ST360 SPINAL FIXATION SYSTEM Zimmer Spine, Inc. KWP Class II 2004-09-24
K042019 HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM Howmedica Osteonics Corp. KTT Class II 2004-09-24
K042312 JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE Smith & Nephew, Inc. KTT Class II 2004-09-24
K042317 CERVICAL PLATE Scient'X KWQ Class II 2004-09-24
K041591 SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS Howmedica Osteonics Corp. JWH Class II 2004-09-23
K041722 MODIFICATION TO VBR SPINAL SYSTEM Depuy Spine, Inc. MQP Class II 2004-09-23
K040070 ARTELON SPACER CMC-1 Artimplant AB KYI Class II 2004-09-21
K042100 BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR Blackstone Medical, Inc. MNI Class II 2004-09-20
K042205 BONE FUSION PLATE SYSTEM Wrightmedicaltechnologyinc HRS Class II 2004-09-20
K042235 ORION ANTERIOR CERVICAL PLATING SYSTEM Medtronic Sofamor Danek KWQ Class II 2004-09-17
K041989 SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X Sintea Biotech, Inc. KWQ Class II 2004-09-16
K042310 ORTHO-PRO CANNULATED BONE SCREWS Ortho-Pro, LLC HWC Class II 2004-09-16
K042295 SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020 Linvatec Biomaterials, Ltd. HWC Class II 2004-09-16
K042237 EBI PERIARTICULAR PLATING SYSTEM Ebi, L.P. HRS Class II 2004-09-16
K042030 HYPROCURE SUBTALAR IMPLANT SYSTEM Graham Medical Technologies, LLC HWC Class II 2004-09-16
K041592 CORAL SPINAL SYSTEM Theken Surgical KWP Class II 2004-09-16
K042244 BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE Triage Medical, Inc. HWC Class II 2004-09-16
K041663 ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM Wrightmedicaltechnologyinc MQV Class II 2004-09-16
K033634 EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED Centerpulse Orthopedics, Inc. KWA Class III 2004-09-15
K042249 CLS SPOTORNO STEM Zimmer Austin, Inc. LZO Class II 2004-09-15
K041862 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek KWP Class II 2004-09-15
K041906 EXACTECH 12/14 TOTAL HIP SYSTEM Exactech, Inc. LPH Class II 2004-09-10
K041617 STALIF TT Surgicraft , Ltd. MQP Class II 2004-09-08
K042325 TROCHANTERIC NAIL SYSTEM DePuy Orthopaedics, Inc. HSB Class II 2004-09-08
K041936 BIOPRO SUBTALAR IMPLANT Biopro, Inc. HWC Class II 2004-09-08
K041911 SYNTHES (USA) LCP CURVED PLATES Synthes (Usa) KTT Class II 2004-09-08
K041786 CALCAMEA PLATE New Deal, S.A. HRS Class II 2004-09-08
K041872 ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS Biomet Manufacturing Corp MBH Class II 2004-09-08
K041706 HOFFMANN II FOOT RING Howmedica Osteonics Corp. KTT Class II 2004-09-08
K041801 EXPEDIUM MIS SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2004-09-08
K041625 LTD POLYAXIAL FIXATION SYSTEM Us Spinal Technologies, LLC KWQ Class II 2004-09-08
K041860 SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG Synthes (Usa) HRS Class II 2004-09-08
K041749 SCANDIUS ACL RECONSTRUCTION SYSTEM Scandius Biomedical, Inc. HWC Class II 2004-09-08
K041709 NUMELOCK II SYSTEM Howmedica Osteonics Corp. KTT Class II 2004-09-08
K042167 MODIFICATION TO: CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2004-09-08
K041965 ARTHREX HUMERAL FRACTURE PLATES AND SCREWS Arthrex, Inc. HRS Class II 2004-09-08
K041777 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek MNI Class II 2004-09-03
K040493 OUTOLOGOUS SPINAL FIXATION SYSTEM Orthopedic Sciences, Inc. MNI Class II 2004-09-03
K041549 ZIMMER TRABECULAR METAL HUMERAL STEM Zimmer, Inc. KWT Class II 2004-09-01
K041533 SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS Synthes (Usa) HWC Class II 2004-09-01

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