meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
33
Latest Decision
1994-03-01

Clearances · page 149 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K931524 FULLY THREADED ALTA CANCELLOUS BONE SCREW Howmedica Corp. HWC Class II 1994-03-01
K932349 ORTHOPEDIC THREADED PIN FIXATION Osteomed Corp. JDW Class II 1994-03-01
K933875 PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE Howmedica Corp. JDI Class II 1994-03-01
K925153 IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM Howmedica Corp. KWY Class II 1994-03-01
K932348 ORTHOPEDIC SMOOTH PIN FIXATION Osteomed Corp. HTY Class II 1994-03-01
K934557 CONTROL CABLE SYSTEM Depuy, Inc. JDQ Class II 1994-02-25
K933738 M. KUROSAKA INTERFERENCE FIXATION SCREW Depuy, Inc. HWC Class II 1994-02-23
K932507 QUICK-CAST IMMOBILIZER Landec Corp. LGF Class I 1994-02-23
K933871 BRIDGE(TM) HIP SYSTEM Wrightmedicaltechnologyinc JDG Class II 1994-02-23
K934469 ARTHROTEK INTERFERENCE SCREW Biomet, Inc. HWC Class II 1994-02-23
K934058 DALL MILES SYSTEM MINICLEAT Howmedica Corp. JDQ Class II 1994-02-23
K932027 OREGON FIXATION SYSTEM INTERFERENCE SCREW Acu Med, Inc. HWC Class II 1994-02-23
K903630 PRECISION OSTEOFLEX FEMORAL COMPONENT Howmedica Corp. JDI Class II 1994-02-23
K933352 CONCEPT CANNULATED INTEREFERENCE SCREW Linvatec Corp. HWC Class II 1994-02-23
K935448 LUHR MINI BONE SCREW AND Z PLATE Howmedica Corp. HRS Class II 1994-02-23
K926229 APC FEMORAL COMPONENT Howmedica Corp. JDI Class II 1994-02-22
K931578 TEXAS SCOTTISH RITE EASY/LOCK FIXATOR Applied Osteo Systems, Inc. JEC Class II 1994-02-22
K931246 CERCLAGE WIRE CRIMP SLEEVE Acu Med, Inc. JDQ Class II 1994-02-22
K933361 ACUMED RADIUS ROD Acu Med, Inc. HSB Class II 1994-02-22
K930223 HOWMEDICA ACETABULAR SHELL Howmedica Corp. JDI Class II 1994-02-22
K934698 HOWMEDICA MONO-TUBE SINGLE PIN CLAMP Howmedica Corp. JEC Class II 1994-02-22
K930107 AME UNIVERSAL BONE SCREW American Medical Electronics, Inc. HWC Class II 1994-02-22
K926228 DURACON CRUCIFORM TIBIAL BASEPLATE Howmedica Corp. JWH Class II 1994-02-22
K930156 MEGA PLUS SUPER LAG SCREW Pfizer Hospital Products Group, Inc. KTT Class II 1994-02-22
K930507 CUSTOM ORTHOPAEDIC TRAYS (PACKS) Associated Medical Products Co. HTS Class I 1994-02-22
K936124 HOWMEDICA MONOTUBE T-CONNECTOR Howmedica, Inc. JEC Class II 1994-02-22
K933027 THE MODULAR NAIL Smith & Nephew Richards, Inc. HSB Class II 1994-02-22
K930460 HOWMEDICA REVISION HIP SYSTEM Howmedica Corp. JDI Class II 1994-02-22
K922071 ZIMMER ANATOMIC HIP SYSTEM Zimmer, Inc. LPH Class II 1994-02-22
K930788 ZIRCONIA CERAMIC FEMORAL HEAD Smith & Nephew Richards, Inc. LZO Class II 1994-02-22
K936045 ACE UNILATERAL FIXATOR II Ace Orthopedic Manufacturing Co. JEC Class II 1994-02-22
K940109 TAVA K-WIRE Tava Surgical Instruments HTY Class II 1994-02-22
K925172 PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE) Howmedica Corp. LPH Class II 1994-02-22
K934440 PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES Howmedica Corp. JDL Class III 1994-02-22
K930833 PCA(R) SOLID BACK ACETABULA SHELL Howmedica Corp. JDL Class III 1994-02-22
K921308 HG MULTILOCK HIP PROSTHESIS W/ TI-NIDIUM Zimmer, Inc. LPH Class II 1994-02-22
K924482 HOWMEDICAL TOTAL KNEE STEM EXTENDER Howmedica Corp. JWH Class II 1994-02-22
K921557 BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT Zimmer, Inc. LPH Class II 1994-02-22
K934176 SURGICAL ACCESSORIES LOOPED WIRE Surgical Accessories, Inc. JDQ Class II 1994-02-22
K934148 TRUE/FLEX CLAVICLE RODS Applied Osteo Systems, Inc. HSB Class II 1994-02-22
K935669 SYRIGENE PRE-FILLED SYRINGE Regulatory & Marketing Services, Inc. JDL Class III 1994-02-18
K925160 ARTHRO FMS 4 Orthoconcept, Inc. HRX Class II 1994-02-17
K933112 ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES Alphatec Mfg., Inc. HRS Class II 1994-02-17
K931665 6.5 MM CANCELLOUS BONE SCREW Encore Orthopedics, Inc. HWC Class II 1994-02-17
K921224 BIMETRIC TOTAL HIP SYSTEM Biomet, Inc. LZO Class II 1994-02-16
K921225 INTEGRAL TOTAL HIP SYSTEM Biomet, Inc. LZO Class II 1994-02-16
K921277 RANAWAT/BURSTEIN TOTAL HIP SYSTEM Biomet, Inc. LPH Class II 1994-02-16
K932858 ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT Dow Corning Wright JWH Class II 1994-02-16
K921301 TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM Biomet, Inc. LPH Class II 1994-02-16
K921181 MALLORY-HEAD TOTAL HIP SYSTEM Biomet, Inc. LZO Class II 1994-02-16
K923452 PMI HIP FEMORAL Biomet, Inc. LPH Class II 1994-02-16
K931321 CSD 200/300/400/500 DYNAMOMETER John Chatillon & Sons, Inc. LBB Class II 1994-02-15
K921274 METALLIC TOATAL HIP SYSTEM Biomet, Inc. LPH Class II 1994-02-15
K931244 BONE PLATE Acu Med, Inc. HRS Class II 1994-02-15
K931214 P.C.A. MODULAR KNEE SYSTEM Howmedica Corp. HSX Class II 1994-02-15
K915655 STABILITY FEMORAL PROSTHESIS W/HAP Depuy, Inc. MEH Class II 1994-02-14
K934270 ACUFEX ARTHROSCOPE Acufex Microsurgical, Inc. HRX Class II 1994-02-14
K934299 DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION Smith & Nephew Dyonics, Inc. HRX Class II 1994-02-14
K930980 INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW Instrument Makar, Inc. HWC Class II 1994-02-10
K931189 P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET Johnson & Johnson Orthopaedics, Inc. LZO Class II 1994-02-09
K920955 APR(R) HIP SYST & NATURAL-HIP(R) FOR UNCEMENT USE Intermedics Orthopedics LPH Class II 1994-02-09
K931187 IMPLEX ACETABULAR CUP SCREW SYSTEM Implex Corp. HWC Class II 1994-02-07
K930531 AME(R) RIGID FIXATION SYSTEM American Medical Electronics, Inc. KWP Class II 1994-02-01
K933772 PUNCH SURGICAL Mahe-Medizintechnik LXH Class I 1994-02-01
K926387 TECHMEDICA STANDARD CEMENTED HIP SYSTEM Techmedica, Inc. KWY Class II 1994-02-01
K926212 ARTHREX INSTRUMENTS ( HIP ) Arthrex, Inc. HRX Class II 1994-01-31
K932653 SWISSTEK 2000(TM) CAST REMOVAL SYSTEM Carapace, Inc. LGH Class I 1994-01-28
K933242 SOFAMOR ORTHOPAEDIC INSTRUMENTS Danek Medical, Inc. LXH Class I 1994-01-28
K933063 ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA Isotechnologies, Inc. KQX Class I 1994-01-27
K935592 SURGICAL ACCESSORIES COCR CABLE SYSTEM Surgical Accessories, Inc. JDQ Class II 1994-01-26
K935481 SPONGER CABLE SYSTEM, MODIFICATION Pioneer Surgical Technology JDQ Class II 1994-01-26
K926303 ARTHREX INSTRUMENTS (WRIST) Arthrex, Inc. HRX Class II 1994-01-26
K933921 ACUFLEX DISPOSABLE KNIVES Acufex Microsurgical, Inc. HTS Class I 1994-01-26
K934260 BARRIER BONE WAX APPLICATOR Phillips Pharmaceuticals, Inc. LXH Class I 1994-01-26
K931733 INTERMEDICS ORTHOPEDICS REAMERS Intermedics Orthopedics HTP Class I 1994-01-26
K924340 P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT Johnson & Johnson Orthopaedics, Inc. JWH Class II 1994-01-25
K931054 TRICK MODULAR KNEE TIBIAL TRAY-POROUS Johnson & Johnson Orthopaedics, Inc. JWH Class II 1994-01-25
K933527 MODIFICATION OF ANTERIOR SEGMENT ELECTRODES Mira, Inc. HWA Class I 1994-01-25
K931846 BIO-PREP Biomedical Devices, Inc. LXH Class I 1994-01-21
K931621 ACUFEX PRO-PAC AND ISO-PAC Acufex Microsurgical, Inc. HRX Class II 1994-01-21
K925072 AMK LANDMARK REVISION KNEE SYSTEM Depuy, Inc. JWH Class II 1994-01-21
K930629 ACRYL-X II SYSTEM Sonokinetics, Inc. LZV Class II 1994-01-21
K925837 AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY Depuy, Inc. JWH Class II 1994-01-07
K921382 FUTURA TEXTURE-TRAKKED TOTAL HIP STEM Arthronics, Inc. LWJ Class II 1994-01-07
K923243 PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. JDI Class II 1994-01-07
K930970 BAUMER SCREWS Baumer Ortopedia , Ltd. HWC Class II 1994-01-07
K930892 MITEK MINI ANCHOR, MODIFICATION Mitek Surgical Products, Inc. JDR Class II 1994-01-07
K922500 PSL TOTAL HIP REPLACEMENT SYSTEM Biopro, Inc. LPH Class II 1994-01-07
K925536 HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. KWY Class II 1994-01-07
K925682 BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED Biopro, Inc. LZO Class II 1994-01-07
K930963 SL-PLUS & SLR-PLUS STEMS W/BIOLOX CERAMIC HEADS Encore Orthopedics, Inc. LZO Class II 1994-01-07
K923514 CLARUS SERIES 2100 ENDOSCOPE Clarus Medical Systems, Inc. HRX Class II 1994-01-07
K925025 PRISM BONE CEMENT MIXING SYSTEM Depuy, Inc. JDZ Class I 1994-01-05
K930125 PHOENIX BONE SCREWS PBS-TYPE SERIES Phoenix Bioengineering, Inc. HXA Class II 1993-12-30
K931672 CARAPACE STERILE CAST PADDING Carapace, Inc. LGF Class I 1993-12-15
K930893 MITEK SUPER QUICKANCHOR, MODIFICATION Mitek Surgical Products, Inc. JDR Class II 1993-12-08
K924016 SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICAL INST. Symbiosis Corp. HRX Class II 1993-12-06
K923011 OSTEONICS UNIX UNICOMPARTMENTAL Osteonics Corp. HRY Class II 1993-11-30
K924141 ORTHOPAEDIC POLYETHYLENE CABLE Smith & Nephew Richards, Inc. JDQ Class II 1993-11-30
K930228 ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE Dow Corning Wright JWH Class II 1993-11-30

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