meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
37
Latest Decision
2005-01-28

Clearances · page 108 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K042321 MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD Biomet Manufacturing Corp KWT Class II 2005-01-28
K042973 SOLITUDE UNIPOLAR HEAD Ortho Development Corp. KWL Class II 2005-01-27
K040497 DISTAL RADIO-ULNAR JOINT IMPLANT Aptis Medical, LLC KXE Class II 2005-01-26
K043583 CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003 Wrightmedicaltechnologyinc HWC Class II 2005-01-26
K043568 EQUESTRA FLUID DELIVERY SYSTEM Medtronic Sofamor Danek HRX Class II 2005-01-25
K040685 Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED Osteoimplant Technology, Inc. LWJ Class II 2005-01-25
K043113 TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE DePuy Orthopaedics, Inc. KTT Class II 2005-01-21
K043560 PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359 Zimmer, Inc. HRS Class II 2005-01-21
K043206 PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER) Pioneer Surgical Technology MQP Class II 2005-01-21
K043514 ALLOGRAN-N-BONE VOID FILLER Biocomposites, Ltd. MQV Class II 2005-01-21
K042774 MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS Biomet, Inc. LPH Class II 2005-01-21
K043102 MULTI-USE COMPRESSION SCREW Wrightmedicaltechnologyinc HWC Class II 2005-01-21
K043281 CHARLOTTE HIGH-DEMAND COMPRESSION SCREW Wrightmedicaltechnologyinc HWC Class II 2005-01-19
K043106 PINN-ACL CROSSPIN Linvatec Corp. HTY Class II 2005-01-19
K043059 COMPRESSION STAPLE AND SIMPLE STAPLE Wrightmedicaltechnologyinc JDR Class II 2005-01-18
K043039 SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE Synthes (Usa) KTT Class II 2005-01-18
K043522 ISSYS PEDICLE SCREW SYSTEM Custom Spine, Inc. KWP Class II 2005-01-14
K043263 TRIMED OSTEOTOMY PLATE TriMed, Inc. HRS Class II 2005-01-14
K042168 CONCORD Radiopaque Bone Cement Globus Medical, Inc. NDN Class II 2005-01-14
K043537 TAPERLOC 12/14 TAPER FEMORAL COMPONENTS Biomet, Inc. LPH Class II 2005-01-14
K043252 CABLING SYSTEM TROCHANTER HOOK Smith & Nephew, Inc. JDQ Class II 2005-01-14
K043395 SMITH & NEPHEW VIDEOARTHROSCOPE Smith & Nephew, Inc. HRX Class II 2005-01-12
K042993 TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT Howmedica Osteonics Corp. JWH Class II 2005-01-12
K042896 SMITH & NEPHEW HYBRID KNEE FEMORAL Smith & Nephew, Inc. NPJ Class II 2005-01-12
K043473 MODIFICATION TO XIA SPINAL SYSTEM Stryker Spine KWP Class II 2005-01-12
K042635 DENALI SPINE SYSTEM K2m, LLC KWP Class II 2005-01-10
K033856 5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN Peter Stevens, MD KTT Class II 2005-01-07
K043020 GLAXY 3.2 SPINAL SYSTEM Medtronic Sofamor Danek KWP Class II 2005-01-07
K040432 SOLAR 2 ANATOMIC SHOULDER Stryker Orthopaedics HSD Class II 2005-01-07
K043045 SYNTHES (USA) CHRONOS Synthes (Usa) MQV Class II 2005-01-07
K041824 X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM Future Medical Systems, SA HRX Class II 2005-01-07
K043566 MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2005-01-07
K043347 BF+ Ldr Spine USA MQV Class II 2005-01-07
K042713 FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5 Spine Next America Corporation MQP Class II 2004-12-29
K042714 FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4 Spine Next America Corporation MQP Class II 2004-12-29
K041407 TITANIUM MESH IMPLANT Interpore Cross Intl. MQP Class II 2004-12-29
K043561 MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2004-12-29
K043403 CEMEX SYSTEM GENTA FAST BONE CEMENT Exactech, Inc. LOD Class II 2004-12-28
K043343 MODIFICATION TO: CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek MNH Class II 2004-12-28
K042930 SPACEVISION CAGE SYSTEM Spine Vision, Inc. MQP Class II 2004-12-28
K042902 HERBERT ULNAR HEAD PROSTHESIS SYSTEM Stuckenbrock Medizintechnik GmbH KXE Class II 2004-12-27
K042911 CEMENTEK LV Teknimed, S.A. MQV Class II 2004-12-27
K042947 PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003 Arthrocare Corp. NDN Class II 2004-12-27
K043404 MODIFICATION TO T2 PROXIMAL HUMERAL NAIL Howmedica Osteonics Corp. HSB Class II 2004-12-27
K042959 DEPUY C-STEM AMT HIP PROSTHESIS DePuy Orthopaedics, Inc. JDI Class II 2004-12-22
K042841 M2A/C2A ACETABULAR SYSTEM Biomet, Inc. JDL Class III 2004-12-21
K043229 MODIFICATION TO ALTIUS OCT SYSTEM Interpore Cross Intl. KWP Class II 2004-12-21
K042871 TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3 Zimmer Trabecular LPH Class II 2004-12-21
K043232 UCR SPINAL SYSTEM Seaspine NKB Class II 2004-12-21
K042789 VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek KWP Class II 2004-12-21
K041850 MEDALLION MODULAR HIP SYSTEM Biomet Manufacturing, Inc. LPH Class II 2004-12-21
K040487 TRABECULAR METAL KNEE SYSTEM AUGMENTS Implex Corp. MBH Class II 2004-12-21
K041950 APEX K2 HIP SYSTEM Apex Surgical, LLC LPH Class II 2004-12-21
K042079 OSS/(SCARF)- AND OSW-SCREW O.M.T. Oberflachen-Und Materialtechnologie GmbH HWC Class II 2004-12-20
K043355 SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X Sintea Biotech, Inc. KWP Class II 2004-12-17
K040047 POLYGRAFT BGS; BONE GRAFT SUBSTITUTE Osteobiologics, Inc. MQV Class II 2004-12-17
K042530 CONSERVE PLUS HA ACETABULAR SHELLS Wrightmedicaltechnologyinc KWA Class III 2004-12-17
K043077 MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM Tornier KWS Class II 2004-12-17
K043181 MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM Vertebron, Inc. KWQ Class II 2004-12-17
K040426 TRANS1 AXIAL FIXATION SYSTEM Trans1, Inc. KWQ Class II 2004-12-17
K042962 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2004-12-14
K042584 OPUS MINIMAGNUM ANCHOR WITH INSERTER Opus Medical, Inc. HWC Class II 2004-12-14
K043337 ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR Arthrex, Inc. HWC Class II 2004-12-14
K032830 PLLA CANNULATED INTERFERENCE SCREW Advanced Biomaterials HWC Class II 2004-12-14
K042636 BIOPLUS Berkeley Advanced Biomaterials, Inc. MQV Class II 2004-12-14
K042552 BIO-CORE INTERFERENCE SCREW Biomet, Inc. HWC Class II 2004-12-14
K042772 EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE Ebi, L.P. NKB Class II 2004-12-13
K043227 PERIARTICULAR LOCKING PLATES, 2358 SERIES Zimmer, Inc. HRS Class II 2004-12-10
K042664 LPS UPPER EXTREMITY Depuy, Inc. JDC Class II 2004-12-08
K043079 BICONTACT HIP SYSTEM WITH U-CAP Aesculap MEH Class II 2004-12-08
K033260 AEQUOS Aap Implantate AG JWH Class II 2004-12-07
K042252 NEXFLEX TOTAL HIP SYSTEM Alphatec/Nexmed LPH Class II 2004-12-06
K042409 MODULAR ARTHRODESIS NAIL Biomet, Inc. HSB Class II 2004-12-02
K043001 MX POLYAXIAL PEDICLE SCREW Scient'X MNH Class II 2004-12-01
K042340 KASIOS TCP Kasios Biomaterials MQV Class II 2004-11-24
K043052 TRIGEN HINDFOOT FUSION NAIL Smith & Nephew, Inc. HSB Class II 2004-11-24
K042859 KOBRA GPS FIXATION SYSTEM Medtronic Vertelink, Inc. KWQ Class II 2004-11-24
K042702 SILHOUETTE SPINAL FIXATION SYSTEM Zimmer Spine, Inc. NKB Class II 2004-11-23
K043082 THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM Signus Medizintechnik GmbH KWQ Class II 2004-11-23
K042544 UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM Depuy Spine, Inc. KWQ Class II 2004-11-23
K043061 THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX Zimmer Trabecular KWS Class II 2004-11-23
K042640 UNI-THREAD SPINAL SYSTEM Spine Vision, Inc. MNH Class II 2004-11-23
K042883 SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT Howmedica Osteonics Corp. JWH Class II 2004-11-23
K031402 PERFECTA FEMORAL STEM Wrightmedicaltechnologyinc LPH Class II 2004-11-22
K042953 MODIFICATION TO PROTEX STABILIZATION SYSTEM Globus Medical, Inc. NKB Class II 2004-11-22
K042964 MX MONOAXIAL PEDICLE SCREW Scient'X MNH Class II 2004-11-22
K042922 VENTURE ANTERIOR CERVICAL PLATING SYSTEM Medtronic Sofamor Danek, Inc. KWQ Class II 2004-11-19
K042966 DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H Linvatec Biomaterials, Ltd. MAI Class II 2004-11-19
K042127 SMITH & NEPHEW MODULAR HIP Smith & Nephew, Inc. MEH Class II 2004-11-19
K042886 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2004-11-18
K042761 WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES Zimmer, Inc. KTT Class II 2004-11-17
K042035 ALUMINA HEAD Fournitures Hospitalieres Industrie LZO Class II 2004-11-17
K041443 OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM Osteoimplant Technology, Inc. LZO Class II 2004-11-16
K042889 DYNAMOMETER - MODEL FCE AND MODEL MSC Ametek LBB Class II 2004-11-16
K042766 ORTHOFIX VOLAR DISTAL RADIAL PLATE Orthofix, Inc. HRS Class II 2004-11-16
K042895 SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES Synthes (Usa) KTT Class II 2004-11-16
K042690 ASCENSION PYROSPHERE (PCS) Ascension Orthopedics, Inc. KYI Class II 2004-11-13
K041595 TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 Biopro, Inc. KWD Class II 2004-11-12
K042914 OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE Opus Medical, Inc. MBI Class II 2004-11-12
K041069 SPIRALOK ANCHOR Depuy Mitek, A Johnson & Johnson Company HWC Class II 2004-11-09

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