meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
30
Latest Decision
2003-09-23

Clearances · page 114 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K030903 OSTEOPAL Heraeus Kulzer GmbH & Co. KG LOD Class II 2003-09-23
K030902 PALACOS R Heraeus Kulzer GmbH & Co. KG LOD Class II 2003-09-23
K031214 CYCLONE ANTERIOR CERVICAL PLATE SYSTEM Encore Medical L.P. KWQ Class II 2003-09-23
K032709 MODULAR PLUS HIP STEM Plus Orthopedics LWJ Class II 2003-09-23
K030904 PALAMED Heraeus Medical GmbH Technology LOD Class II 2003-09-23
K024125 HALM ZIELKE INSTRUMENTATION SYSTEM Micomed Ortho GmbH KWQ Class II 2003-09-22
K032187 ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM Arthrex, Inc. HRS Class II 2003-09-22
K032380 WAGNER CONE PROSTHESIS Centerpulse Orthopedics, Inc. LZO Class II 2003-09-22
K030867 ESKA MODULAR HIP SYSTEM CEMENTED Eska Implants GmbH JDI Class II 2003-09-22
K032169 CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) Cyberorthology, Inc. LXT Class II 2003-09-22
K031945 ARTHREX TRIMIT SCREW, MODEL AR-4161B Arthrex, Inc. HWC Class II 2003-09-22
K023983 MODIFICATION TO HIGHGATE CURVED ROD SYSTEM Highgate Orthopaedics KWQ Class II 2003-09-22
K032110 PROCLASS PRESS FIT HIP STEM Stelkast Company LWJ Class II 2003-09-22
K031280 ULTRA-DRIVE 3 Biomet, Inc. JDX Class II 2003-09-22
K031967 TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MNI Class II 2003-09-17
K031855 SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM Spinal Concepts, Inc. KWQ Class II 2003-09-17
K032578 TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MNI Class II 2003-09-17
K032269 SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES Synthes (Usa) HRS Class II 2003-09-17
K032529 HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 Hydrocision, Inc. HRX Class II 2003-09-16
K031972 ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00, Asap Endoscopic Products GmbH HRX Class II 2003-09-15
K032212 KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A Kyphon, Inc. HRX Class II 2003-09-15
K032033 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2003-09-12
K032588 MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) Disco-O-Tech Medical Technologies, Ltd. HSB Class II 2003-09-12
K032163 DURACON TOTAL KNEE SYSTEM Howmedica Osteonics Corp. MBH Class II 2003-09-12
K031985 SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM Spinal Concepts, Inc. MNI Class II 2003-09-11
K032418 DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING Howmedica Osteonics Corp. MBH Class II 2003-09-11
K032548 IP-XS COMPRESSION NAIL SYSTEM Plus Orthopedics HSB Class II 2003-09-10
K032507 INTERLOK BIO-MODULAR HUMERAL STEMS Biomet, Inc. KWT Class II 2003-09-05
K031973 SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE Synthes (Usa) LXT Class II 2003-09-05
K031772 TI FENESTRATED PLATE Interpore Cross Intl. KWP Class II 2003-09-05
K032032 SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES Synthes (Usa) HRS Class II 2003-09-04
K031937 ALANTECH GRAFT FIXATION SCREW Arthrocare Corp. HWC Class II 2003-09-04
K032037 CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) Medtronic Sofamor Danek MNI Class II 2003-09-04
K032479 HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS Howmedica Osteonics Corp. JWH Class II 2003-09-04
K031919 EBI XFIX DFS SYSTEM Ebi, L.P. KTT Class II 2003-09-04
K031833 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek MNI Class II 2003-09-03
K031729 TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM Howmedica Osteonics Corp. JWH Class II 2003-09-02
K024313 MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM Pisharodi Surgicals, Inc. MNI Class II 2003-08-29
K031730 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS Howmedica Osteonics Corp. JDI Class II 2003-08-29
K032579 S2 NAIL SYSTEM Howmedica Osteonics Corp. HSB Class II 2003-08-29
K030237 KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT Kapp Surgical Instrument, Inc. KWI Class II 2003-08-29
K032409 VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER Orthovita, Inc. MQV Class II 2003-08-29
K031712 INION OTPS BIODEGRADABLE PIN Inion , Ltd. HTY Class II 2003-08-28
K032078 MITEK MICRO QUICKANCHOR Mitek Worldwide NOV Class II 2003-08-25
K031155 OSTEOMED SUBTALAR IMPLANT SYSTEM Osteomed LP HWC Class II 2003-08-22
K031677 SYNTHES (USA) CALVICLE HOOK PLATE Synthes (Usa) HRS Class II 2003-08-21
K032396 RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS Biomet, Inc. JDI Class II 2003-08-21
K032295 GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT Smith & Nephew, Inc. JWH Class II 2003-08-21
K030367 COLUMBUS (PS) Aesculap, Inc. JWH Class II 2003-08-21
K023884 MODIFICATION ORIA SPINAL SYSTEM Ortho Tec, LLC KWP Class II 2003-08-20
K031651 MODIFICATION TO CERASORB ORTHO Curasan AG MQV Class II 2003-08-13
K030384 EVOLVE CERAMIC RADIAL HEAD IMPLANT Wrightmedicaltechnologyinc KWI Class II 2003-08-12
K032367 ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL Zimmer, Inc. HSB Class II 2003-08-12
K030055 MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS Biomet, Inc. LPH Class II 2003-08-11
K032228 LORENZ 2.4 SELF DRILLING SCREWS Walter Lorenz Surgical, Inc. HWC Class II 2003-08-11
K032265 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek KWQ Class II 2003-08-11
K032264 MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM Howmedica Osteonics Corp. HSD Class II 2003-08-08
K031702 REFLEX ANTERIOR CERVICAL PLATE SYSTEM Howmedica Osteonics KWQ Class II 2003-08-08
K032224 BIORCI SCREW Smith & Nephew, Inc. HWC Class II 2003-08-08
K032244 GAMMA 3 NAIL SYSTEM Howmedica Osteonics Corp. HSB Class II 2003-08-08
K031744 OMNIFIT HFX HIP STEM SERIES Howmedica Osteonics Corp. JDI Class II 2003-08-08
K030369 OPUS SPINAL SYSTEM Howmedica Osteonics Corp. NKB Class II 2003-08-08
K030302 HBS HEADLESS BONE SCREW Schoening & Assoc., Inc. HWC Class II 2003-08-08
K032097 DEPUY ACE VERSANAIL TIBIAL NAIL DePuy Orthopaedics, Inc. HSB Class II 2003-08-08
K032197 TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212 Smith & Nephew, Inc. MAI Class II 2003-08-08
K031428 SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE Synthes (Usa) LXT Class II 2003-08-08
K032215 VKS/TC-PLUS REVISION KNEE Plus Orthopedics JWH Class II 2003-08-08
K031672 SPINAL CONCEPTS, INC. INFIX SYSTEM Spinal Concepts, Inc. MQP Class II 2003-08-07
K031462 THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS Implex Corp. MBH Class II 2003-08-06
K031693 MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA Biomet, Inc. LPH Class II 2003-08-06
K031354 EBI OMEGA21 SPINAL FIXATION SYSTEM Ebi, L.P. MNI Class II 2003-08-06
K031401 FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) Disco-O-Tech Medical Technologies, Ltd. KTT Class II 2003-08-06
K031435 BONESOURCE BVF Howmedica Osteonics MQV Class II 2003-08-04
K031480 GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT Howmedica Osteonics Corp. KRO Class II 2003-07-31
K031757 PEEK TETRIS SPINAL IMPLANT Signus Medical, LLC MQP Class II 2003-07-30
K031780 VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2003-07-30
K031381 UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS Seaspine MNI Class II 2003-07-30
K032058 MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES Alliance Medical Corp. KTT Class II 2003-07-30
K030766 OXINIUM FEMORAL HEADS Smith & Nephew, Inc. JDI Class II 2003-07-25
K032059 MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM Aesculap, Inc. KWQ Class II 2003-07-25
K031981 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 Linvatec Biomaterials, Ltd. MAI Class II 2003-07-25
K032052 UC-PLUS SOLUTION UNICONDYLAR KNEE Plus Orthopedics HRY Class II 2003-07-25
K031959 STRYKER PLATING SYSTEM PERIARTICULAR PLATES Howmedica Osteonics Corp. LXT Class II 2003-07-25
K031941 HOFFMANN II COMPACT BALTIMORE COUPLING Howmedica Osteonics Corp. JEC Class II 2003-07-24
K031040 THERIFIL BONE FILLER Therics, Inc. MQV Class II 2003-07-24
K031355 EBI SPINELINK - II SPINAL FIXATION SYSTEM Ebi, L.P. NKB Class II 2003-07-22
K031424 EBI SPINELINK SPINAL FIXATION SYSTEM Ebi, L.P. NKB Class II 2003-07-22
K031893 XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM Howmedica Osteonics Corp. KWP Class II 2003-07-17
K031817 CELLPLEX TCP SYNTHETIC CANCELLOUS BONE Wrightmedicaltechnologyinc MQV Class II 2003-07-17
K030087 SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM Spinal Concepts, Inc. NKB Class II 2003-07-17
K031438 ACUMED SMALL BONE LOCKING ROD SYSTEM II Acumed, LLC HSB Class II 2003-07-17
K030288 POLYGRAFT BONE GRAFT SUBSTITUTE Osteobiologics, Inc. MQV Class II 2003-07-17
K031319 OSTEO-G BONE VOID FILLER SYSTEM Aspine USA, Inc. MQV Class II 2003-07-17
K031201 ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM Ortho Development Corp. JWH Class II 2003-07-15
K031203 BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST DePuy Orthopaedics, Inc. JWJ Class II 2003-07-14
K031050 PCW PERCUTANEOUS COMPRESSION WIRE Millennium Medical Technologies, Inc. HWC Class II 2003-07-14
K031724 SYNTHES SMALL COBINATION CLAMP-MR SAFE Synthes (Usa) KTT Class II 2003-07-14
K031183 TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE Centerpulse Orthopedics, Inc. JWH Class II 2003-07-14
K031181 EXTERNAL FIXATION SYSTEMS Smith & Nephew, Inc. KTT Class II 2003-07-14
K031914 SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE Spinal Concepts, Inc. MQP Class II 2003-07-12

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