meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
35
Latest Decision
2002-12-11

Clearances · page 117 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K023299 ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM Alphatec Mfg., Inc. MNI Class II 2002-12-11
K023777 ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183 Arthronet Medical, Inc. HRX Class II 2002-12-11
K021039 BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM Depuyacromed KWQ Class II 2002-12-11
K023188 PRESS-FIT HEAD RESURFACING DEVICE Biomet Orthopedics, Inc. KXA Class II 2002-12-11
K023267 T2 SUPRACONDYLAR NAIL SYSTEM Howmedica Osteonics Corp. HSB Class II 2002-12-11
K014296 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek KWP Class II 2002-12-10
K020085 SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X Sintea Biotech, Inc. MNH Class II 2002-12-10
K023786 DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER DePuy Orthopaedics, Inc. KWA Class III 2002-12-10
K022377 THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306 Implex Corp. KWT Class II 2002-12-10
K021233 AAP CANNULATED SCREWS Aap Implantate AG HWC Class II 2002-12-09
K022997 SPECTRUM CERVICAL SPINAL SYSTEM Spinal Innovations, LLC KWQ Class II 2002-12-06
K023007 DISTAL RADIUS FRACTURE REPAIR SYSTEM Hand Innovations, Inc. HRS Class II 2002-12-05
K022985 ASCENDENT ACETABULAR SYSTEM Sulzer Orthopedics, Inc. LZO Class II 2002-12-05
K021489 REPIPHYSIS LIMB SALVAGE SYSTEM Wrightmedicaltechnologyinc KRO Class II 2002-12-04
K022048 INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM Interpore Cross Intl. KWP Class II 2002-12-04
K021859 WRIST IMPLANT Avanta Orthopaedics, Inc. JWJ Class II 2002-12-02
K022952 MODULAR HEAD BONE SCREW Biomet, Inc. HWC Class II 2002-12-02
K023187 KSEA SPINOSCOPE Karl Storz Endoscopy HRX Class II 2002-12-02
K023604 MODIFICATION TO RADIAL HEAD IMPLANT Avanta Orthopaedics, Inc. KWI Class II 2002-11-27
K013072 CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) Synthes MQV Class II 2002-11-26
K022887 INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM Osteomed Corp. KWH Class II 2002-11-26
K023675 SYNTHES CERVIFIX/ AXON Synthes (Usa) KWP Class II 2002-11-26
K022892 ASCENSION SILLICONE MCP Ascension Orthopedics, Inc. KYJ Class II 2002-11-25
K022886 METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM Osteomed Corp. KWH Class II 2002-11-25
K022853 ENDOTACK KARL STORZ Endoscopy-America, Inc. MBI Class II 2002-11-25
K023644 MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM Spinal Concepts, Inc. MNI Class II 2002-11-25
K023555 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek, Inc. KWP Class II 2002-11-22
K022827 ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR Linvatec Corp. MBI Class II 2002-11-22
K022799 TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE Howmedica Osteonics Corp. JDI Class II 2002-11-21
K022779 OTI UNICONDULAR INTERPOSITIONAL SPACER Osteoimplant Technology, Inc. HSH Class II 2002-11-20
K021679 ORIA SPINAL CLIP SYSTEM Ortho Tec, LLC KWP Class II 2002-11-19
K023570 MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2002-11-19
K022798 CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES CATALOGUE NUMBERS Corin USA KWQ Class II 2002-11-19
K022729 VENTED CEMENT RESTRICTOR Amedica Corp. JDX Class II 2002-11-14
K023437 FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL Disco-O-Tech Medical Technologies, Ltd. HSB Class II 2002-11-14
K023646 EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM Exactech, Inc. JDI Class II 2002-11-13
K023438 MODIFICATION TO MONARCH SPINE SYSTEM Depuyacromed MNH Class II 2002-11-13
K023453 DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS DePuy Orthopaedics, Inc. JDI Class II 2002-11-13
K022791 SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM Synthes (Usa) KWQ Class II 2002-11-13
K023498 MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM Blackstone Medical, Inc. KWP Class II 2002-11-13
K022768 AMT POLYAXIAL PEDICLE SCREW Micron Precision Engineering, Inc. MNI Class II 2002-11-13
K020703 SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING Howmedica Osteonics Corp. JWH Class II 2002-11-13
K023562 MODIFICATION TO CLASSIC GREAT TOE IMPLANT Nexa Orthopedics, Inc. KWH Class II 2002-11-13
K023409 HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS Biomet, Inc. LPH Class II 2002-11-08
K023416 MODIFICATION TO VKS KNEE SYSTEM Plus Orthopedics JWH Class II 2002-11-08
K022672 COLUMBUS TOTAL KNEE SYSTEM (CR) Aesculap, Inc. JWH Class II 2002-11-08
K023417 SURETAC III, MODELS 7209900, 7209901 Smith & Nephew, Inc. JDR Class II 2002-11-07
K023357 ARCPM 1050 RESIN-HIPS Biomet Orthopedics, Inc. LPH Class II 2002-11-06
K022629 WMT-TCP BONE GRAFT SUBSTITUTE Wrightmedicaltechnologyinc MQV Class II 2002-11-05
K022597 K-FIX New Deal, S.A. HTY Class II 2002-11-01
K021551 STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT Biocomposites, Ltd. MQV Class II 2002-11-01
K022599 NEWDEAL K WIRE New Deal, S.A. HTY Class II 2002-10-30
K023375 MODIFICATION TO ESOP CO-CR FEMORAL HEADS Pro-Active Healthcare LPH Class II 2002-10-25
K021564 INCOMPASS SPINAL FIXATION SYSTEM Spinal Concepts, Inc. KWQ Class II 2002-10-25
K023360 LEFORTE SYSTEM BONE PLATE Jeil Medical Corporation KTW Class II 2002-10-25
K023302 ECHELON POROUS PLUS HA HIP STEMS Smith & Nephew, Inc. MEH Class II 2002-10-25
K021661 RINGLOC CONSTRAINED LINERS Biomet Orthopedics, Inc. KWZ Class II 2002-10-25
K021728 RINGLOC CONSTRAINED LINERS II Biomet, Inc. KWZ Class II 2002-10-25
K023399 EBI XFIX DFS SYSTEM Ebi, L.P. KTT Class II 2002-10-25
K023260 1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM Osteomed Corp. HWC Class II 2002-10-18
K023133 MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM Ebi, L.P. KWQ Class II 2002-10-18
K022204 VKS KNEE SYSTEM Plus Orthopedics JWH Class II 2002-10-18
K023204 MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM Ebi, L.P. MNH Class II 2002-10-18
K021451 DURACON CS TIBIAL INSERT Howmedica Osteonics Corp. JWH Class II 2002-10-18
K023314 MICROFIX Fixano SA KTT Class II 2002-10-18
K023324 MODIFICATION TO EBI XFIX DFS SYSTEM Ebi, L.P. KTT Class II 2002-10-18
K022403 GMRS PRESS FIT STEMS WITH PUREFIX HA Howmedica Osteonics Corp. LZO Class II 2002-10-17
K023186 OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY Exactech, Inc. JWH Class II 2002-10-17
K023203 OSSTAPLE Biomedical Ent., Inc. JDR Class II 2002-10-17
K022651 HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT Howmedica Osteonics Corp. LXT Class II 2002-10-17
K023211 NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS Zimmer, Inc. JWH Class II 2002-10-17
K023085 RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM Biomet Orthopedics, Inc. JDI Class II 2002-10-17
K021351 BIOSTEON CROSS PIN Biocomposites, Ltd. HWC Class II 2002-10-17
K020948 SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II Smith & Nephew, Inc. JDR Class II 2002-10-09
K023134 JET-X TIN COATED HALF PINS Smith & Nephew, Inc. JDW Class II 2002-10-09
K023294 BOSWORTH CORACO-CLAVICULAR SCREW Howmedica Osteonics Corp. HWC Class II 2002-10-09
K023102 ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM Howmedica Osteonics Corp. MEH Class II 2002-10-09
K022207 AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM Axya Medical, Inc. MBI Class II 2002-10-04
K023021 MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T Smith & Nephew, Inc. HWC Class II 2002-10-04
K023086 CLASSIC GREAT TOE IMPLANT Nexa Orthopedics, Inc. KWH Class II 2002-10-04
K023022 NUGEN FX SCREW Bionx Implants, Inc. HWC Class II 2002-10-04
K022382 RHS ACETABULAR COMPONENT Signal Medical Corp. LPH Class II 2002-10-04
K022234 ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B Arthrex, Inc. HWC Class II 2002-10-03
K022958 TOTAL HIP FEMORAL HEADS AND LINERS Smith & Nephew, Inc. JDI Class II 2002-10-02
K022966 PROXILOCK HIP PROSTHESIS; SIZE 12/36 Implex Corp. LWJ Class II 2002-10-02
K022199 ENDIUS ATAVI SYSTEM Endius, Inc. HRX Class II 2002-10-02
K022902 SMITH & NEPHEW HIP SYSTEM Smith & Nephew, Inc. LPH Class II 2002-10-02
K020457 AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE Axiamed, Inc. HRX Class II 2002-09-26
K022344 TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM Centerpulse Spine-Tech, Inc. KWQ Class II 2002-09-24
K022374 CADENCE SPINAL FIXATION SYSTEM Sulzer Spine-Tech KWP Class II 2002-09-24
K022079 SHORT AND LONG SOFT TISSUE ATTACHMENT Biomet, Inc. KWT Class II 2002-09-24
K022632 SIGN IM NAIL Surgical Implant Generation Network (Sign) HSB Class II 2002-09-23
K021740 TOTAL KNEE CEMENTED, SEMI-CONSTRAINED Dj Orthopedics, LLC JWH Class II 2002-09-23
K022549 RESTORATION MODULAR SYSTEM Howmedica Osteonics Corp. LZO Class II 2002-09-23
K022139 HIP TOOL IMPLANT Orthopedic Sciences, Inc. HRS Class II 2002-09-23
K022676 ORTHOGUARD AB ANTIMICROBIAL SLEEVE Smith & Nephew, Inc. JEC Class II 2002-09-23
K022771 TWIN FIX Fixano SA KTT Class II 2002-09-23
K022271 PLUS PIVOT LINK UNIVERSAL SYSTEM Spine Vision, Inc. MNI Class II 2002-09-23
K022778 MODIFICATION TO TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MNI Class II 2002-09-18
K021761 PREMIER ANTERIOR CERVICAL PLATE SYSTEM Medtronic Sofamor Danek KWQ Class II 2002-09-17

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