meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
40
Latest Decision
2005-12-01

Clearances · page 104 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K051858 ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM Exactech, Inc. LZO Class II 2005-12-01
K053098 OPTIUM DBM GEL AND PUTTY Lifenet MBP Class II 2005-11-28
K051821 INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM Inion , Ltd. OJB Class II 2005-11-25
K043048 GRAFTON PLUS DBM PASTE Osteotech, Inc. MBP Class II 2005-11-23
K052255 ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS Biomet, Inc. LPH Class II 2005-11-23
K053038 HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM Howmedica Osteonics Corp. KTT Class II 2005-11-22
K053002 DEPUY CMW 1 GENTAMICIN BONE CEMENT DePuy Orthopaedics, Inc. MBB Class II 2005-11-22
K052196 VILEX X-FIX Vilex, Inc. KTT Class II 2005-11-22
K053003 DEPUY CMW 1, 2 AND 3 BONE CEMENTS DePuy Orthopaedics, Inc. LOD Class II 2005-11-22
K052879 NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS Zimmer, Inc. JWH Class II 2005-11-22
K051826 BETACONE HIP PROSTHESIS SYSTEM Waldemar Link GmbH & Co. KG LWJ Class II 2005-11-18
K050398 EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS Exactech, Inc. LZO Class II 2005-11-18
K051722 TRICOS T Baxter Healthcare Corp MQV Class II 2005-11-18
K053053 PACP SYSTEM Pioneer Surgical Technology KWQ Class II 2005-11-16
K052971 STRYKER SPINE TRIO SPINAL FIXATION SYSTEM Stryker Spine MNI Class II 2005-11-16
K052931 MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2005-11-16
K052624 INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE Inion , Ltd. HRS Class II 2005-11-16
K052950 THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM Zimmer Trabecular MQP Class II 2005-11-16
K052405 STERLING INTERFERENC SCREW HT Regeneration Technologies, Inc. HWC Class II 2005-11-16
K051023 TOPEZ TOTAL ANKLE REPLACEMENT Topez Orthopedics, Inc. HSN Class II 2005-11-15
K052596 MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 Biopro, Inc. KYI Class II 2005-11-15
K050473 RBK PATELLA FEMORAL KNEE Global Orthopaedic Technology, USA, Inc. KRR Class II 2005-11-14
K052201 SOLANAS POSTERIOR STABILIZATION SYSTEM Alphatec Spine, Inc. KWP Class II 2005-11-10
K052763 STELLA CERVICAL PLATE Scient'X KWQ Class II 2005-11-10
K052605 EXTERNAL FIXATION Gexfix USA, Inc. KTT Class II 2005-11-10
K042691 VERTEFIX VERTEBROPLASTY PROCEDURE SET Cook, Inc. NDN Class II 2005-11-08
K052607 ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS Arthrex, Inc. HWC Class II 2005-11-07
K052913 IGNITE BONE VOID FILLER KIT Wrightmedicaltechnologyinc MQV Class II 2005-11-07
K052406 UNI-THREAD SPINAL SYSTEM Spine Vision, Inc. MNI Class II 2005-11-07
K052576 SBI AUTOFIX Small Bone Innovations, LLC HWC Class II 2005-11-07
K050407 LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60 Sciences For Bio Materials HWC Class II 2005-11-04
K052483 SYNTHES (USA) SPHERICAL WASHERS Synthes (Usa) NDG Class II 2005-11-04
K051205 STRYKER SPINE AVS ASL PEEK SPACER Stryker Spine MQP Class II 2005-11-04
K052494 NOVABONE-BIOACTIVE SYNTHETIC GRAFT Novabone Products, LLC MQV Class II 2005-11-03
K052533 KIMBA SPINAL IMPLANT Signus Medizintechnik GmbH MQP Class II 2005-11-03
K051914 GENEROS 80, GENEROS 60 Berkeley Advanced Biomaterials, Inc. MQV Class II 2005-11-03
K052137 ASCENSION MUH Ascension Orthopedics, Inc. KXE Class II 2005-11-03
K052736 ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT Arthrex, Inc. HTY Class II 2005-11-03
K052747 MODIFICATION TO:CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2005-10-28
K052718 V40 BIOLOX DELTA CERAMIC FEMORAL HEADS Howmedica Osteonics Corp. LZO Class II 2005-10-27
K052754 WRIST FUSION PLATE Dvo Extremity Solutions, LLC LXT Class II 2005-10-27
K052685 ORTHOPEDIC SALVAGE SYSTEM- OSS Biomet, Inc. KRO Class II 2005-10-27
K051721 GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM Global Orthopaedic Technology, USA, Inc. HRY Class II 2005-10-26
K051089 GII SPINAL FIXATION SYSTEM Co-Ligne AG MNH Class II 2005-10-26
K051656 OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM Osteobiologics, Inc. HRX Class II 2005-10-25
K052041 COLLAGEN BONE HEALING PROTECTIVE SHEET Collagen Matrix, Inc. HRS Class II 2005-10-25
K051948 AVON PATELLO-FEMORAL JOINT PROSTHESIS Howmedica Osteonics Corp. KRR Class II 2005-10-21
K052294 SHOULDER NAIL PLATE Hand Innovations, LLC HRS Class II 2005-10-21
K052609 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2005-10-21
K052746 CONCORDE VBR SPINAL SYSTEM Depuy Spine, Inc. MQP Class II 2005-10-21
K052079 PINNACLE CONSTRAINED ACETABULAR LINERS DePuy Orthopaedics, Inc. KWZ Class II 2005-10-21
K052631 SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) Depuy Mitek, A Johnson & Johnson Company JDR Class II 2005-10-21
K052734 MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek KWP Class II 2005-10-21
K052292 SPIDER CERVICAL PLATING (SCP) SYSTEM X-Spine Systems, Inc. KWQ Class II 2005-10-21
K051531 TECTONIC CERVICAL PLATE SYSTEM K2m, LLC KWQ Class II 2005-10-17
K052498 FRAGMENT SPECIFIC FIXATOR David J. Slutsky MD KTT Class II 2005-10-17
K051976 PROVEN REVISION MODULAR TIBIAL TRAY Stelkast Company JWH Class II 2005-10-17
K052630 ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) Depuy Mitek, A Johnson & Johnson Company HWC Class II 2005-10-17
K052368 OLECRANONPLATE WITH ANGULAR STABILITY I.T.S. Implantat-Technologie-Systeme GmbH HRS Class II 2005-10-17
K051815 MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM Vertebron, Inc. KWQ Class II 2005-10-17
K052552 HYBRID ANTERIOR CERVICAL PLATE SYSTEM Depuy Spine, Inc. KWQ Class II 2005-10-13
K052677 SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP) Synthes (Usa) HRS Class II 2005-10-12
K051959 NV CORMED SOLAS SPINAL SYSTEM Nv Cormed MNH Class II 2005-10-12
K051977 SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS Howmedica Osteonics Corp. JWH Class II 2005-10-12
K050373 UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS Arthrosurface, Inc. HSX Class II 2005-10-11
K052761 MODIFICATION TO: XIA 4.5 SPINAL SYSTEM Stryker Spine MNI Class II 2005-10-11
K051844 EQUATOR PLUS ACETABULAR CUP SYSTEM Portland Orthopaedics Pty. , Ltd. MAY Class II 2005-10-07
K052261 MODIFICATION TO: VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. MQP Class II 2005-10-07
K052384 LANX VBR SYSTEM Lanx, LLC MQP Class II 2005-10-07
K052390 SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION Synthes (Usa) HRS Class II 2005-10-07
K052792 ANTHOLOGY HIP STEM Smith & Nephew, Inc. JDI Class II 2005-10-07
K052538 S-BONE HIP TOOL Orthopedic Sciences, Inc. HRS Class II 2005-10-07
K052491 AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR Axya Medical, Inc. MBI Class II 2005-10-07
K051044 ARCTEC SEMIRIGID PLATING SYSTEM Altiva Corp. MNH Class II 2005-10-07
K050997 EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE Flexuspine, Inc. MQP Class II 2005-10-07
K052472 DEPUY GLOBAL SHOULDER CROSSLINK GLENOID DePuy Orthopaedics, Inc. KWS Class II 2005-10-06
K050124 POROUS COATED ACETABULAR COMPONENTS Biomet, Inc. KWA Class III 2005-10-04
K051698 MERRIES UNI-OSTEO, MODEL CS30250-CS10102 Merries International, Inc. MQV Class II 2005-09-29
K051569 RINGLOC BI-POLAR ACETABULAR COMPONENT Biomet, Inc. JDI Class II 2005-09-29
K051843 COPELAND EAS HUMERAL RESURFACING HEADS Biomet, Inc. HSD Class II 2005-09-29
K043099 LINEAGE HA ACETABULAR SHELLS Wrightmedicaltechnologyinc KWA Class III 2005-09-29
K052131 EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS Depuy Spine, Inc. KWP Class II 2005-09-28
K051951 CERAMENT BONE VOID FILLER Bonesupport AB MQV Class II 2005-09-28
K052614 LOW PROFILE PLATE AND SCREW SYSTEM Arthrex, Inc. HRS Class II 2005-09-28
K051726 ARTHREX TENODESIS FAMILY Arthrex, Inc. HWC Class II 2005-09-27
K050327 E-POLY (VITAMIN E) ACETABULAR LINERS Biomet, Inc. LPH Class II 2005-09-27
K052309 DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 Saehan Corp. LBB Class II 2005-09-27
K052542 ACCOLADE RPS HIP STEM Stryker Orthopaedics LZO Class II 2005-09-27
K051741 ACCOLADE HFX FEMORAL STEM Stryker Orthopaedics LZO Class II 2005-09-26
K052123 SYNTHES PANGEA SYSTEM Synthes (Usa) KWP Class II 2005-09-23
K052402 VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek KWP Class II 2005-09-23
K052376 MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek KWP Class II 2005-09-23
K051978 TRABECULAR METAL VERTEBRAL BODY REPLACEMENT Implex Corp. MQP Class II 2005-09-23
K050637 ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS Ortho Development Corp. JDI Class II 2005-09-23
K051697 SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM Medical Device Advisory Development Group MNH Class II 2005-09-21
K052239 EBI DYNAFIX VISION FOOTPLATE SYSTEM Ebi, L.P. KTT Class II 2005-09-21
K052317 MODIFICATION TO: STRYKER SPINE OASYS SYSTEM Stryker Spine MNI Class II 2005-09-21
K051957 REPROCESSED EXTERNAL FIXATION DEVICE Sterilemed, Inc. KTT Class II 2005-09-21
K051678 SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM Synthes (Usa) HSB Class II 2005-09-21
K052248 DORSAL NAIL PLATE, ANATOMICAL Hand Innovations, LLC HRS Class II 2005-09-14

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