meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
28
Latest Decision
1995-03-22

Clearances · page 145 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K945973 FMS ARTHROSCOPY CANNULA Future Medical Systems, Inc. HRX Class II 1995-03-22
K932070 DURACON STABILIZER FEMORAL COMPONENT AND INSERT Howmedica Corp. JWH Class II 1995-03-22
K950541 HOWMEDICA V40 22MM FEMORAL HEAD Howmedica Corp. LWJ Class II 1995-03-21
K935383 FEMROD AND FEMROD RECON INSERT Applied Osteo Systems, Inc. HSB Class II 1995-03-21
K943548 BIOABSORBABLE INTERFERENCE SCREW Acufex Microsurgical, Inc. JDR Class II 1995-03-20
K946026 HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS Howmedica, Inc. LZO Class II 1995-03-20
K945087 ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE Wrightmedicaltechnologyinc JWH Class II 1995-03-17
K945691 OSTEONICS(R) THREADED HA ACETABULAR SHELLS Osteonics Corp. MEH Class II 1995-03-17
K946313 TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER Smith and Nephew Donjoy, Inc. HRX Class II 1995-03-17
K942900 OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM Osteonics Corp. MEH Class II 1995-03-15
K943450 ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970 Arthrocare Corp. HRX Class II 1995-03-13
K933494 EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM Exactech, Inc. JWH Class II 1995-03-10
K934515 BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB) Zimmer, Inc. LPH Class II 1995-03-07
K945670 KIRSCHNER (K-WIRE), STEINMAN PINS Brasseler USA I, L.P. JDW Class II 1995-03-07
K945294 DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE Howmedica Corp. JDQ Class II 1995-03-07
K945203 MITEK THRADED ANCHOR (MTA) Mitek Surgical Products, Inc. JDR Class II 1995-03-06
K945613 DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT Howmedica Corp. HSX Class II 1995-03-06
K950027 CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK Intermedics Orthopedics JDQ Class II 1995-03-06
K941534 MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM 3M Health Care, Ltd. KWY Class II 1995-03-06
K943774 OSTEONICS RESTORATION MONOLITHIC HIP STEM Osteonics Corp. LZO Class II 1995-03-06
K943957 RESTORATION HA ACETABULAR CUP SERIES Osteonics Corp. MEH Class II 1995-03-06
K943937 MANUAL INSTRUMENTS Pantheon Surgical Products HRX Class II 1995-03-06
K944529 CABLE-EASE PLATE AND CABLE SYSTEM Intermedics Orthopedics JDQ Class II 1995-02-17
K942387 SELBY INSTRUMENTATION Advanced Spine Fixation Systems, Inc. MNH Class II 1995-02-14
K932024 CCG CERCLAGE SYSTEM Encore Orthopedics, Inc. JDQ Class II 1995-02-14
K944210 ARTHROSCOPE ACCESSORIES Stryker Endoscopy HRX Class II 1995-02-14
K945516 NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM Intermedics Orthopedics LZO Class II 1995-02-14
K943819 ISOLA ANTERIOR SYSTEM Acromed Corp. KWQ Class II 1995-02-09
K941029 OGDEN ANCHOR-SMALL (TENTATIVE) American Medical Electronics, Inc. JDR Class II 1995-02-09
K934867 ACUFEX TAG ANCHOR Acufex Microsurgical, Inc. JDR Class II 1995-02-09
K932690 EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY Exactech, Inc. JWH Class II 1995-02-09
K943694 EBI ANTERIOR CERVICAL SPINE SYSTEM Electro-Biology, Inc. KWQ Class II 1995-02-08
K934381 APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT Intermedics Orthopedics JWH Class II 1995-02-08
K941306 FOUNDATION KNEE AUGMENTATION BLOCKS Encore Orthopedics, Inc. JWH Class II 1995-02-08
K935789 POSTERIOR STABILIZED APOLLO KNEE SYSTEM Intermedics Orthopedics JWH Class II 1995-02-06
K940297 UNIVERSAL WRIST Turnkey Intergration USA, Inc. JWI Class II 1995-02-06
K945236 AIMS CANNULATED ACL SCREW (7MM DIAMETER) Smith and Nephew Donjoy, Inc. HWC Class II 1995-02-03
K941941 BONE MULCH SCREW Biomet, Inc. HWC Class II 1995-02-02
K943426 ARTHROSCOPE,RIGID ROD-LENS DIAGNOSTIC ENDOSCOPE Schoelly Technologies, Inc. HRX Class II 1995-02-01
K944831 INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENER Innovasive Devices, Inc. MBI Class II 1995-02-01
K945233 PEDIATRIC OSTEOTOMY SYSTEM Howmedica Corp. KTT Class II 1995-02-01
K943492 ARTHREX STAPLES Arthrex, Inc. JDR Class II 1995-02-01
K931381 AME UNIVERSAL FIXATION SYSTEM American Medical Electronics, Inc. KWP Class II 1995-02-01
K941769 KNEE PROTHESIS Joint Medical Products Corp. JWH Class II 1995-02-01
K935065 OGDEN ANCHOR ADDITIONAL APPLICATIONS American Medical Electronics, Inc. JDR Class II 1995-01-30
K933785 NEXT GENERATION KNEE SYSTEM Zimmer, Inc. JWH Class II 1995-01-30
K940813 OSTEONICS(R) SERIES 7000 TOTAL KNEE Osteonics Corp. JWH Class II 1995-01-30
K933229 APOLLO KNEE FEMORAL COMPONENT Intermedics Orthopedics JWH Class II 1995-01-27
K933995 TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION Applied Osteo Systems, Inc. HSB Class II 1995-01-27
K943857 EXTERNAL FIXATOR Acu Med, Inc. JEC Class II 1995-01-27
K943299 DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY Depuy, Inc. JWH Class II 1995-01-27
K944842 ARTHROSCOPE 5 Star Medical, Inc. HRX Class II 1995-01-24
K945182 DYONICS FIXATION SCREWS Smith & Nephew Dyonics, Inc. HWC Class II 1995-01-24
K943853 DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM Wrightmedicaltechnologyinc HRS Class II 1995-01-20
K932029 TSRH SPINAL SCREWS Sofamor Danek Mfg., Inc. MNH Class II 1995-01-20
K945094 HNR-PC HIP Howmedica Corp. LZO Class II 1995-01-19
K940307 HOWMEDICA STRAIGHT STEM FEMORAL COMPONENT Howmedica, Inc. JDI Class II 1995-01-19
K945095 APC FEMORAL COMPONENT Howmedica Corp. LZO Class II 1995-01-19
K945093 P.C.A. E-SERIES HIP- CEMENTLESS USE Howmedica, Inc. LZO Class II 1995-01-19
K945090 HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD Howmedica Corp. LZO Class II 1995-01-19
K945092 P.C.A.PRIMARY HIP- CEMENTLESS USE Howmedica Corp. LZO Class II 1995-01-19
K940389 S.T.E.P. UNI-KNEE S.T.E.P. Orthopaedics, Inc. HRY Class II 1995-01-19
K945089 SENTRY TOTAL HIP Howmedica Corp. LZO Class II 1995-01-19
K945096 CDH HIP STEM Howmedica Corp. LZO Class II 1995-01-19
K930836 HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM Howmedica Corp. KTT Class II 1995-01-18
K941651 CTS RELIEF KIT Linvatec Corp. HRX Class II 1995-01-18
K936274 KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM Kirschner Medical Corp. JWH Class II 1995-01-18
K945091 HOWMEDICA ALUMINA FEMORAL HEAD Howmedica Corp. LZO Class II 1995-01-18
K941755 ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZED ALL POLYTHYLENE TIBIAL COMPONENT Wrightmedicaltechnologyinc JWH Class II 1995-01-17
K933610 EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS Exactech, Inc. JWH Class II 1995-01-17
K942298 THE KARL STORZ ARTHROPUMP KARL STORZ Endoscopy-America, Inc. HRX Class II 1995-01-17
K944601 ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD Zimmer, Inc. LZO Class II 1995-01-12
K921525 HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS Implant Technology, Inc. LPH Class II 1995-01-11
K942537 PARAMOUNT CEMENTED HIP STEM PROTHESIS Depuy, Inc. JDI Class II 1995-01-09
K942300 SILKON TITANIUM CABLE SYSTEM American Medical Electronics, Inc. JDQ Class II 1995-01-09
K933958 RICHARDS TOTAL KNEE SYSTEM Smith & Nephew Richards, Inc. JWH Class II 1995-01-09
K944132 P.F.C. TOTAL HIP SYSTEM Johnson & Johnson Professionals, Inc. KWY Class II 1995-01-06
K944752 ORTHOMET RESURFACING FEMORAL COMPONENT Orthomet, Inc. KXA Class II 1994-12-28
K942906 AGEE-WRISTJACK PRE-DRILL KIT Hand Biomechanics Lab, Inc. HTW Class I 1994-12-22
K940729 PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES Pioneer Surgical Technology JDQ Class II 1994-12-21
K943462 DARWIN KNEE SYSTEM Johnson & Johnson Professionals, Inc. JWH Class II 1994-12-21
K943906 P.F.C. CEMENT PRESSURIZING SYSTEM Johnson & Johnson Professionals, Inc. KIH Class I 1994-12-21
K934334 APOGEE HIP STEM WITH POROCOAT Depuy, Inc. LPH Class II 1994-12-21
K943943 TRANSTIBIAL ACL DISPOSABLES KIT Arthrex, Inc. HRX Class II 1994-12-20
K943782 BONE SCREW WASHER Acu Med, Inc. HTN Class II 1994-12-20
K943523 ANTERIOR CERVIAL PLATING SYSTEM Smith & Nephew Richards, Inc. KWQ Class II 1994-12-19
K944285 OSTEONICS SERIES 7000 TOTAL KNEE FEMORAL COMPONENTS Osteonics Corp. JWH Class II 1994-12-19
K943549 RESTORATION ACETABULAR CUP Osteonics Corp. JDI Class II 1994-12-19
K935913 HOWMEDICA SENTRY S TOTAL HIP SYSTEM Howmedica, Inc. LZO Class II 1994-12-15
K942787 BONE ANCHOR Acu Med, Inc. JDR Class II 1994-12-15
K944845 ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENT Wrightmedicaltechnologyinc JWH Class II 1994-12-15
K940230 ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS Instratek, Inc. HRX Class II 1994-12-12
K935773 EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT Exactech, Inc. JWH Class II 1994-12-09
K944209 APR II NON POROUS HIP STEM Intermedics Orthopedics LZO Class II 1994-12-09
K944213 6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW Howmedica Corp. HWC Class II 1994-12-09
K943804 BONE SCREW Cohort Medical Products Group, Inc. HWC Class II 1994-12-08
K944769 P.F.C. APICAL PLUG Johnson & Johnson Professionals, Inc. JDL Class III 1994-12-08
K941128 OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS Osteonics Corp. JWH Class II 1994-12-08
K943154 KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS KARL STORZ Endoscopy-America, Inc. HRX Class II 1994-12-06
K931466 PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI Johnson & Johnson Orthopaedics, Inc. JWH Class II 1994-12-06

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