meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
32
Latest Decision
2003-03-24

Clearances · page 116 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K022949 SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS Synthes (Usa) MNI Class II 2003-03-24
K030501 X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS Biomet, Inc. LPH Class II 2003-03-20
K023192 STRYKER BIOZIP SUTURE ANCHOR Stryker Endoscopy HWC Class II 2003-03-20
K024291 ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 Arthrex, Inc. HRX Class II 2003-03-20
K030368 KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW KARL STORZ Endoscopy-America, Inc. HWC Class II 2003-03-20
K030500 ORIA ZENITH Ortho Tec, LLC KWQ Class II 2003-03-20
K023692 GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER Howmedica Osteonics Corp. LWJ Class II 2003-03-20
K030597 SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES Synthes (Usa) HRS Class II 2003-03-20
K030706 EBI DYNAFIX COMPRESSION BONE SCREW Ebi, L.P. HWC Class II 2003-03-20
K030096 VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW Arthrex, Inc. HRX Class II 2003-03-18
K024364 SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW) Synthes (Usa) MQP Class II 2003-03-17
K024115 MICROFIX QUICKANCHOR PLUS Mitek Worldwide HWC Class II 2003-03-13
K024096 OPTIMA, SPINAL SYSTEM U&I Corp., America MNI Class II 2003-03-12
K023564 OSSE-LIGN Osseus, LLC JDQ Class II 2003-03-11
K030377 MODIFICATION TO SYNTHES CERVIFIX SYSTEM Synthes (Usa) MNI Class II 2003-03-06
K030372 MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM Ebi, L.P. KTT Class II 2003-03-06
K030336 KMEDIC EXTERNAL FIXATION DEVICES Teleflex Medical Group JDW Class II 2003-03-06
K030373 ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM Centerpulse Orthopedics, Inc. LZO Class II 2003-03-06
K030446 REPICCI LOCKED KEEL TIBIAL BEARING Biomet, Inc. HRY Class II 2003-03-06
K023377 ORIA CERVICAL PLATES Ortho Tec, LLC KWQ Class II 2003-03-04
K023319 NUVASIVE MASH Nuvasive, Inc. MQP Class II 2003-03-04
K021878 ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS Eska America Corp. LPH Class II 2003-03-04
K024336 MIIG II BONE GRAFT SUBSTITUTE Wrightmedicaltechnologyinc MQV Class II 2003-03-04
K030344 MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS Smith & Nephew, Inc. KWS Class II 2003-03-04
K030265 CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 Zimmer, Inc. JDI Class II 2003-03-04
K024340 SMITH & NEPHEW FEMORAL HEADS Smith & Nephew, Inc. JDI Class II 2003-02-26
K030327 ZEPHIR ANTERIOR CERVICAL SYSTEM Medtronic Sofamor Danek KWQ Class II 2003-02-26
K030383 MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS Depuyacromed MNH Class II 2003-02-26
K023013 STRYKER XCEL ANCHOR SYSTEM Stryker Endoscopy HWC Class II 2003-02-26
K024049 VERTE-SPAN SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MQP Class II 2003-02-26
K030178 CALCIGEN PSI BONE GRAFT SUBSTITUTE Biomet, Inc. MQV Class II 2003-02-26
K022251 PALABOND Heraeus Kulzer GmbH & Co. KG LOD Class II 2003-02-26
K010555 JAX Smith & Nephew, Inc. MQV Class II 2003-02-25
K030285 MODIFICATION TO TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. NKB Class II 2003-02-25
K022520 U2 ACETABULAR CUP United Orthopedic Corp. LPH Class II 2003-02-25
K030301 UNICONDYLAR FEMORAL COMPONENT Smith & Nephew, Inc. JWH Class II 2003-02-25
K030253 ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 Ortho Tec, LLC KWP Class II 2003-02-21
K030252 ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07) Ortho Tec, LLC KWP Class II 2003-02-21
K030241 MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM Blackstone Medical, Inc. KWP Class II 2003-02-21
K030266 CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ Berkeley Advanced Biomaterials, Inc. MQV Class II 2003-02-20
K030236 ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT Exactech, Inc. LPH Class II 2003-02-20
K030196 DYONICS POWER CONTROL UNIT Smith & Nephew, Inc. HRX Class II 2003-02-20
K030193 ADVANCE LESS CONFORMING TIBIAL COMPONENT Wrightmedicaltechnologyinc HRY Class II 2003-02-20
K030249 SURGICAL TITANIUM MESH SYSTEM Depuyacromed MQP Class II 2003-02-14
K023012 SMARTSET HV BONE CEMENT DePuy Orthopaedics, Inc. LOD Class II 2003-02-13
K030307 DAVOL ARTHROVENT OUTFLOW TUBING Davol, Inc. HRX Class II 2003-02-13
K023783 SOHNIKS Sohniks Endoscopy, Inc. HRX Class II 2003-02-07
K020885 FASSIRE-DUVAL TELESCOPIC IM SYSTEM Pega Medical, Inc. HSB Class II 2003-02-06
K024233 KOMPRESSOR SCREW SYSTEM Kinetikos Medical, Inc. HWC Class II 2003-02-06
K030048 HA PMI FEMORAL HIP STEM Biomet Orthopedics, Inc. LPH Class II 2003-02-05
K023921 JET-X HA COATED HALF PINS Smith & Nephew, Inc. JDW Class II 2003-02-05
K030079 VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS Zimmer, Inc. LPH Class II 2003-02-05
K030103 SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS Depuyacromed MNI Class II 2003-02-05
K023879 SMALL TITANIUM WRIST FUSION PLATE Synthes (Usa) HRS Class II 2003-02-05
K023994 ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ Ortho Tec, LLC MNH Class II 2003-02-05
K030122 DEPUY SUMMIT BASIC PRESS-FIT HIP STEM DePuy Orthopaedics, Inc. LWJ Class II 2003-02-05
K030037 UNIVERSAL TOTAL WRIST SYSTEM Kinetikos Medical, Inc. JWJ Class II 2003-02-05
K023724 DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT Howmedica Osteonics Corp. JWH Class II 2003-02-03
K023714 REPROCESSED EXTERNAL FIXATION DEVICE Alliance Medical Corp. KTT Class II 2003-02-03
K023703 BI-OSTETIC Berkeley Advanced Biomaterials, Inc. MQV Class II 2003-01-30
K023835 DEVEX MESH SYSTEM Depuyacromed MQP Class II 2003-01-29
K023901 ALUMINA V40 FEMORAL HEADS Howmedica Osteonics Corp. LZO Class II 2003-01-28
K024348 MONARCH SPINE SYSTEM Depuyacromed MNH Class II 2003-01-28
K021963 BIOSORB RESORBABLE VOID FILLER Sciences ET Bio Materiaux (Sbm) MQV Class II 2003-01-28
K023851 PRECIMED HIP SCREW SYSTEM Precimed, Inc. KTT Class II 2003-01-28
K023802 SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM Synthes (Usa) HRS Class II 2003-01-28
K023804 MOSS MIAMI SPINAL SYSTEM PIN NUT Depuyacromed KWP Class II 2003-01-23
K023941 SYNTHES TOMOFIX OSTEOTOMY SYSTEM Synthes (Usa) KTT Class II 2003-01-23
K022143 INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD) Interpore Cross Intl. MQP Class II 2003-01-23
K024022 OSTEO-CABLE SLEEVE Biomet, Inc. HXN Class I 2003-01-23
K030047 FREEDOM CONSTRAINED LINERS Biomet, Inc. KWZ Class II 2003-01-23
K024326 SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM Spinal Concepts, Inc. KWQ Class II 2003-01-23
K023743 SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM Smith & Nephew, Inc. KWY Class II 2003-01-23
K024248 MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM Ebi, L.P. KTT Class II 2003-01-22
K023546 MAXIM ACCEL KNEE SYSTEM Biomet, Inc. JWH Class II 2003-01-17
K023531 LESSER METATARSAL PHALANGEAL JOINT IMPLANT Nexa Orthopedics, Inc. KWH Class II 2003-01-17
K023528 NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE Centerplus Orthopedics, Inc. JWH Class II 2003-01-17
K024129 MODIFICATION TO EBI XFIX DFS SYSTEM Ebi, L.P. KTT Class II 2003-01-15
K024134 UNI HIP STEM Plus Orthopedics LWJ Class II 2003-01-15
K024161 NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS Implex Corp. JWH Class II 2003-01-15
K024086 PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM Biomet Orthopedics, Inc. HWC Class II 2003-01-09
K022622 CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P Berkeley Advanced Biomaterials, Inc. MQV Class II 2003-01-09
K024037 NARROW ASCENT INTERLOK FEMORAL COMPONENTS Biomet, Inc. JWH Class II 2002-12-30
K023388 MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM Mitek Worldwide JDR Class II 2002-12-27
K023241 TELEGRAPH HUMERAL NAIL Fournitures Hospitalieres Industrie HSB Class II 2002-12-24
K023667 RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE Plus Orthopedics KRO Class II 2002-12-24
K021826 TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES Zimmer, Inc. KWZ Class II 2002-12-20
K021953 MITEK PDS/PGA STAPLE Mitek Worldwide JDR Class II 2002-12-20
K023922 COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 Coapt Systems, Inc. HWC Class II 2002-12-20
K024060 MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM Howmedica Osteonics Corp. HWC Class II 2002-12-20
K023862 NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER Synthes (Usa) MQV Class II 2002-12-19
K021803 REFLECTION CONSTRAINED LINER Smith & Nephew, Inc. KWZ Class II 2002-12-19
K023115 ACE VERSANAIL DePuy Orthopaedics, Inc. HSB Class II 2002-12-18
K023119 BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B Arthrex, Inc. HTN Class II 2002-12-18
K023087 GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS) Howmedica Osteonics Corp. KRO Class II 2002-12-16
K023063 COMPREHENSIVE HUMERAL FRACTURE SYSTEM Biomet Orthopedics, Inc. KWT Class II 2002-12-13
K023415 MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM Medtronic Sofamor Danek KWP Class II 2002-12-13
K023797 LAURAIN DEWALD ANTERIOR FIXATION SYSTEM Medtronic Sofamor Danek KWP Class II 2002-12-13
K023788 COLUMBUS (CR) TOTAL KNEE SYSTEM Aesculap, Inc. JWH Class II 2002-12-13
K023770 K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) Kinetikos Medical, Inc. KWD Class II 2002-12-12

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