meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
36
Latest Decision
2003-12-18

Clearances · page 113 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K033763 MODIFICATION TO SLIM GLIDING NAIL SYSTEM Plus Orthopedics KTT Class II 2003-12-18
K033524 COAPT ENDOTINE CHIN 3.5 DEVICE Coapt Systems, Inc. HWC Class II 2003-12-18
K031804 COMPRESS DISTAL FEMORAL REPLACEMENT Biomet, Inc. KRO Class II 2003-12-18
K030086 PALACOS R BONE CEMENT WITH GENTAMICIN Biomet, Inc. LOD Class II 2003-12-17
K033664 MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM Centerpulse Orthopedics, Inc. LZO Class II 2003-12-17
K032358 B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) Disc-O-Tech Medical Technologies, Ltd. HRX Class II 2003-12-17
K033322 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek MNH Class II 2003-12-15
K033740 LORENZ STERNAL CLOSURE SYSTEM Walter Lorenz Surgical, Inc. HWC Class II 2003-12-15
K032679 AEQUALIS SHOULDER FRACTURE SYSTEM Tornier KWS Class II 2003-12-15
K032902 SUBTALAR ARTHRORISIS IMPLANT Nexa Orthopedics, Inc. HWC Class II 2003-12-15
K032102 VERTELINK KOBRA SPINAL FIXATION SYSTEM Vertelink Corporation KWQ Class II 2003-12-12
K032268 MBCP Biomatlante MQV Class II 2003-12-11
K033669 SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS) Smith & Nephew, Inc. HRS Class II 2003-12-10
K032829 SCORPIO LOW PROFILE TIBIAL TRAY Howmedica Osteonics Corp. JWH Class II 2003-12-10
K032855 STRYKER SPINE MAPS SYSTEM Howmedica Osteonics MNH Class II 2003-12-10
K032812 ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT Orthovita, Inc. MQP Class II 2003-12-08
K033519 CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET Biomet, Inc. HRS Class II 2003-12-05
K032659 DEPUY ASR RESURFACING FEMORAL HEADS DePuy Orthopaedics, Inc. KXA Class II 2003-12-04
K033516 DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS DePuy Orthopaedics, Inc. HSD Class II 2003-12-03
K033529 TIE-IN TRAPEZIUM Wrightmedicaltechnologyinc KYI Class II 2003-12-03
K032752 R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM R&B Surgical Solutions, LLC KWQ Class II 2003-12-03
K033495 MODIFICATION TO EQUATION FIXATION SYSTEM Medtronic Sofamor Danek, Inc. MNI Class II 2003-12-03
K033635 MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM Ebi, L.P. KTT Class II 2003-12-03
K033510 MODIFICATION TO TELEGRAPH HUMERAL NAIL Fournitures Hospitalieres Industrie HSB Class II 2003-12-03
K032729 Z-SERIES MODULAR TOTAL HIP SYSTEM Osteoimplant Technology, Inc. LPH Class II 2003-12-03
K033138 CAP3 BONE SUBSTITUTE MATERIAL Etex Corp. MQV Class II 2003-12-02
K031826 TRIHA + Teknimed, S.A. MQV Class II 2003-11-28
K033509 MODIFICATION TO VERSABOND BONE CEMENT Smith & Nephew, Inc. LOD Class II 2003-11-28
K030319 ORTHOSPHERE CERAMIC SPHERICAL IMPLANT Wrightmedicaltechnologyinc KWD Class II 2003-11-26
K033411 SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS Synthes (Usa) KTT Class II 2003-11-26
K033442 REFLECTION CONSTRAINED LINER Smith & Nephew, Inc. KWZ Class II 2003-11-26
K032895 BI-ANGULAR SHOULDER SYSTEM Biomet, Inc. MBF Class II 2003-11-20
K030958 ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS Ortho Tec, LLC MNI Class II 2003-11-20
K032739 UCR SPINAL SYSTEM Seaspine MNI Class II 2003-11-20
K031493 GROWTH GUIDANCE PLATE University of Utah/School of Medicine HRS Class II 2003-11-20
K030978 SCORPIO NRG KNEE SYSTEM Howmedica Osteonics Corp. JWH Class II 2003-11-20
K032286 CALCIGEN PSI BONE GRAFT SUBSTITUTE Biomet Orthopedics, Inc. MQV Class II 2003-11-20
K031666 ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS Arthrex, Inc. HRS Class II 2003-11-18
K021478 DELTA SHOULDER Depuy, Inc. PHX Class II 2003-11-18
K032094 PASSMED SPINAL SYSTEM Medicrea KWP Class II 2003-11-14
K031175 CLICK'X MONOAXIAL SCREWS AND HOOKS Synthes (Usa) KWP Class II 2003-11-14
K033329 DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS Depuy, Inc. HSB Class II 2003-11-14
K032964 EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS Exactech, Inc. LPH Class II 2003-11-13
K032824 STELKAST UNICONDYLAR KNEE SYSTEM Stelkast Company HSX Class II 2003-11-13
K033252 MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM Stryker Endoscopy HWC Class II 2003-11-13
K032476 NUVASIVE MESH Nuvasive, Inc. MQP Class II 2003-11-13
K032473 DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE Stryker Instruments HRX Class II 2003-11-07
K033271 DYNALOK CLASSIC SPINAL SYSTEM Medtronic Sofamor Danek MNI Class II 2003-11-06
K033034 VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS Zimmer, Inc. LPH Class II 2003-11-05
K033233 LACTOSORB TIBIAL L-15 SCREW AND WASHER Biomet, Inc. HWC Class II 2003-11-05
K033145 HOFFMANN II PELVIC CLAMP Howmedica Osteonics Corp. LXT Class II 2003-11-05
K033112 WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS Hand Biomechanics Lab, Inc. KTT Class II 2003-11-05
K033158 SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES Synthes (Usa) KTT Class II 2003-11-05
K032130 VITOSS-FILLED CARTRIDGE Orthovita, Inc. MQV Class II 2003-11-05
K033071 SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM Synthes (Usa) JDS Class II 2003-11-05
K032398 PLUS PIVOT LINK UNIVERSAL SYSTEM Spine Vision, Inc. MNI Class II 2003-10-31
K032527 HEDROCEL VERTEBRAL BODY REPLACEMENT Implex Corp. MQP Class II 2003-10-31
K031963 CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD Wrightmedicaltechnologyinc KWA Class III 2003-10-31
K032385 GLOBAL PRESS-FIT STEM Global Medical Co. LPH Class II 2003-10-30
K030082 POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851 Richard Wolf Medical Instruments Corp. HRX Class II 2003-10-30
K031838 PROFUSION BONE VOID FILLER KIT Biogeneration MQV Class II 2003-10-30
K032348 CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP Centerpulse Orthopedics, Inc. LZO Class II 2003-10-24
K031455 CONKLUSION PEDICLE SCREW SYSTEM Signus Medical, LLC MNI Class II 2003-10-22
K032532 TARAS THREADED FIXATION PIN Union Surgical, LLC JDW Class II 2003-10-22
K032686 ASCENSION MODULAR RADIAL HEAD Ascension Orthopedics, Inc. KWI Class II 2003-10-22
K032523 T2 NAILING SYSTEM Howmedica Osteonics Corp. HSB Class II 2003-10-22
K031875 INTER-OS LIMB LENGTHENER Inter-Os Technologies KTT Class II 2003-10-22
K032559 SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS Synthes (Usa) HRS Class II 2003-10-22
K032682 STS SCREW Ortho-Pro, LLC HWC Class II 2003-10-22
K032726 ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES Zimmer, Inc. LPH Class II 2003-10-22
K030256 ISO-ELASTIC CERCLAGE SYSTEM Kinamed, Inc. JDQ Class II 2003-10-21
K032167 BIO-INTRAFIX TIBIAL SCREW AND SHEATH Mitek Worldwide HWC Class II 2003-10-15
K032683 GENESIS II POROUS PLUS HA KNEE SYSTEM Smith & Nephew, Inc. MBH Class II 2003-10-15
K031474 SC TOTAL HIP SYSTEM Orthopedic Alliance, LLC JDI Class II 2003-10-15
K032413 KLS-MARTIN STERNAL PLATING SYSTEM KLS-Martin L.P. HRS Class II 2003-10-10
K031901 PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT Stelkast Company JWH Class II 2003-10-10
K031471 ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01 Ortho Tec, LLC KWP Class II 2003-10-10
K032427 FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM Meridan Medical JEC Class II 2003-10-09
K032898 T2 RECON NAIL SYSTEM Howmedica Osteonics Corp. HSB Class II 2003-10-09
K032581 GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT Howmedica Osteonics Corp. LPH Class II 2003-10-09
K031061 NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS Zimmer, Inc. MBH Class II 2003-10-09
K032368 SONOMA ANTERIOR CERVICAL PLATE SYSTEM Seaspine KWQ Class II 2003-10-09
K032300 ACCOLADE-J HIP STEM SERIES Howmedica Osteonics Corp. MEH Class II 2003-10-09
K032700 BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS Blackstone Medical, Inc. MQP Class II 2003-10-09
K031265 SHIRAZ-JAVA SPINAL FIXATION SYSTEM Spine Next SA MNH Class II 2003-10-09
K032770 ENDOTINE FOREHEAD DEVICE Coapt Systems, Inc. HWC Class II 2003-10-08
K032098 ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B Arthrex, Inc. HWC Class II 2003-10-07
K032634 NORMED COMPRESSION BONE SCREW SYSTEM Noviace Corporation JDS Class II 2003-10-06
K032687 ACE NANCY NAIL DePuy Orthopaedics, Inc. HTY Class II 2003-10-06
K030923 EPSILON DURASUL CONSTRAINED ACETABULAR LINER Centerpulse Orthopedics, Inc. KWZ Class II 2003-10-03
K032079 HLS NOETOS SYSTEM Tornier JWH Class II 2003-10-02
K032072 LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE Arthrotek, Inc. HWC Class II 2003-10-01
K032722 TRIGEN STRAIGHT HUMERAL NAIL SYSTEM Smith & Nephew, Inc. HSB Class II 2003-10-01
K032705 DISTAL RADIUS FRACTURE REPAIR SYSTEM Hand Innovations, Inc. LXT Class II 2003-10-01
K023103 DEPUY 1 GENTAMICIN BONE CEMENT DePuy Orthopaedics, Inc. LOD Class II 2003-09-29
K032151 DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS Depuy, Inc. JWH Class II 2003-09-26
K032832 IRRIGATION SETS Vital Concepts, Inc. HRX Class II 2003-09-26
K031971 GLOBAL CAP RESURFACING REPLACEMENT SHOULDER DePuy Orthopaedics, Inc. HSD Class II 2003-09-24
K032606 OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS Exactech, Inc. JWH Class II 2003-09-23
K031449 MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION Implex Corp. KWS Class II 2003-09-23

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