meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
29
Latest Decision
1992-12-10

Clearances · page 152 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K922865 NEER TYPE SHOULDER PROSTHESIS SYSTEM Osteo Technology, Inc. KWT Class II 1992-12-10
K922550 ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM) Verimed Holdings, Inc. KQX Class I 1992-12-10
K923583 ORTHOMET PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. LZO Class II 1992-12-07
K910993 MORREY ELBOW FIXATOR Howmedica Corp. KTT Class II 1992-11-25
K924656 TRUE/ FLEX FIBULA RODS Applied Osteo Systems, Inc. HSB Class II 1992-11-24
K924492 POLY-DIAL INSERTS Joint Medical Products Corp. LPH Class II 1992-11-24
K920739 S-ROM TOTAL HIP REPLACEMENT SYSTEM Joint Medical Products Corp. JDI Class II 1992-11-24
K924115 ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS Johnson & Johnson Orthopaedics, Inc. JDI Class II 1992-11-24
K924657 TRUE/FLEX METATARSAL RODS Applied Osteo Systems, Inc. KTW Class II 1992-11-24
K924004 SEIDEL HUMERAL LOCKING NAIL -- ADDITIONAL LENGTHS Howmedica Corp. JDS Class II 1992-11-23
K922142 FX-CABLELOK SYSTEM Bio-Tech Co. JDQ Class II 1992-11-20
K922520 MODIFIED TSRH CENTRAL POST HOOKS Sofamor Danek Mfg., Inc. KWP Class II 1992-11-16
K923807 P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS Johnson & Johnson International JWH Class II 1992-11-09
K921836 PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD Orthomet, Inc. LZO Class II 1992-11-06
K922087 ANTERIOR CERVICAL PLATE SYSTEM Sofamor Danek Mfg., Inc. KWQ Class II 1992-11-06
K923776 BENDEREV DRILL GUIDE Neimark Labs, Inc. HXY Class I 1992-11-06
K923898 C-FIT CEMENTED HIP STEM Turnkey Intergration USA, Inc. JDI Class II 1992-11-04
K915641 ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER Biomet, Inc. LZO Class II 1992-11-04
K920290 KINAMED 32MM BIOCERAM-Z TOATAL HIP FEMORAL BALL Kinamed, Inc. LZO Class II 1992-11-03
K920219 KINAMED 26MM BIOCERAN-Z TOTAL HIP FEMORAL BALL Kinamed, Inc. LZO Class II 1992-10-30
K923339 TSRH L CONNECTOR -- MODIFICATION Sofamor Danek Mfg., Inc. KWP Class II 1992-10-27
K924665 QUICKANCHOR Mitek Surgical Products, Inc. JDR Class II 1992-10-27
K923262 DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETER John Chatillon & Sons, Inc. LBB Class II 1992-10-27
K922292 LUNDEEN SUBTALAR PEG IMPLANT Sgarlato Laboratories, Inc. MJW Class II 1992-10-23
K921111 S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD Joint Medical Products Corp. LZO Class II 1992-10-22
K915889 MITEK BONE ANCHOR, MODIFICATION Mitek Surgical Products, Inc. JDR Class II 1992-10-22
K915396 OSTEONICS ZIRCONIA C-TAPER FEMORAL BEARING HEAD Osteonics Corp. LZO Class II 1992-10-20
K915500 LESTER PRESS FIT HIP PROSTHESIS Kirschner Medical Corp. JDI Class II 1992-10-20
K923451 AMK MODULAR POROUS COATED TITANIUM TIBIAL TRAY Depuy, Inc. JWH Class II 1992-10-20
K922421 KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP Kinamed, Inc. JDI Class II 1992-10-15
K920145 BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM Biopro, Inc. LZO Class II 1992-10-15
K921823 ARTHREX ARTHROSCOPY ICE BLADE Arthrex, Inc. HRX Class II 1992-10-15
K924514 ACUFEX FIXATION POST Acufex Microsurgical, Inc. HWC Class II 1992-10-13
K923256 ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW Alphatec Mfg., Inc. HWC Class II 1992-10-09
K920117 HALO ESPRIT Itm Corp. JEC Class II 1992-10-06
K922029 REMUSK MP Equipement Biomedical Specialise, Inc. LBB Class II 1992-10-06
K922940 CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002 Exos, Inc. LBB Class II 1992-10-05
K922525 DALL MILES BROAD BONE PLATE Howmedica Corp. HRS Class II 1992-09-22
K922266 ALTA FEMORAL INTRAMEDULLARY ROD SYSTEM, ADD SIZES Howmedica Corp. HSB Class II 1992-09-21
K922503 HOWMEDICA(R) HNR SYSTEM Howmedica Corp. JDI Class II 1992-09-21
K922824 KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYM Joint Medical Products Corp. HSX Class II 1992-09-17
K922557 ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT Acufex Microsurgical, Inc. HRX Class II 1992-09-17
K920454 CLEARTRAC CANNULA Acufex Microsurgical, Inc. HRX Class II 1992-09-16
K922560 CONSENSUS(TM) BIPOLAR SYSTEM U.S. Medical Products, Inc. KWY Class II 1992-09-11
K922734 AXIOM TOTAL KNEE SYSTEM AND PLUS TOTAL KNEE SYSTEM Orthomet, Inc. JWH Class II 1992-09-10
K922295 OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATION Howmedica Corp. KTT Class II 1992-09-08
K921640 KINEMAX PLUS ALL PLASTIC TIBIAL COMPONENT Howmedica Corp. JWH Class II 1992-09-08
K922048 DURACON ALL PLASTIC TIBIAL COMPONENT Howmedica Corp. JWH Class II 1992-09-08
K922620 AMK FIXED STEM CEMENTED TIBIAL TRAY Depuy, Inc. JWH Class II 1992-09-03
K920080 CONTINUUM KNEE SYSTEM Techmedica, Inc. JWH Class II 1992-09-01
K920593 CERAMIC FEMORAL HEAD Dow Corning Wright LZO Class II 1992-08-31
K912837 MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS Kirschner Medical Corp. KWP Class II 1992-08-26
K915512 DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS Pfizer Hospital Products Group, Inc. JWH Class II 1992-08-18
K922391 ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS Instratek, Inc. HRX Class II 1992-08-18
K922285 AGC AND MAXIM KNEE COMPONENTS WITH NTS Biomet, Inc. JWH Class II 1992-08-13
K922146 OSTRONCS HEMI-HIP STEM SERIES Osteonics Corp. KWL Class II 1992-08-11
K922104 7000 SERIES TOTAL KNEE MODULAR COMPONENT CEMENT CA Osteonics Corp. JWH Class II 1992-08-11
K920256 SPINE MOTION ANALYZER WITH EMG Orthopedic Systems, Inc. KQX Class I 1992-08-10
K910992 AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE Depuy, Inc. JWH Class II 1992-08-10
K922318 DOUGLAS MEDICAL PRODUCTS, INC. IRRIGATION SET Douglas Medical Products Corp. HRX Class II 1992-08-10
K921672 INTER-HA HIP PROSTHESIS Kirschner Medical Corp. MEH Class II 1992-08-07
K920396 KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM Kirschner Medical Corp. JWH Class II 1992-08-07
K914675 MODULAR FEMORAL HEAD WITH OFFSET TRUNION Kirschner Medical Corp. JDI Class II 1992-08-07
K922167 ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES Alphatec Mfg., Inc. HRS Class II 1992-08-06
K922166 ALPHATEC SMALL FRAGMENT SET Alphatec Mfg., Inc. HWC Class II 1992-08-06
K922322 ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW Alphatec Mfg., Inc. HWC Class II 1992-08-05
K920666 INTRAMEDULARY FIXATION ROD Acu Med, Inc. HSB Class II 1992-08-05
K922144 CITSCOPE (MODEL EXTENSIONS) Citation Medical Corp. HRX Class II 1992-08-05
K920426 PSK FEMORAL AND TIBIAL INSERT COMPONENT Orthomet, Inc. JWH Class II 1992-08-03
K920698 FEMORAL AND ALL POLY TIBIAL TRAY COMPONENTS Orthomet, Inc. JWH Class II 1992-08-03
K922008 CDH HIP SYSTEM Howmedica, Pfizer Medical Technology Group JDI Class II 1992-07-30
K914878 ZIRCONIUM ALLOY FRMORAL HEAD Smith & Nephew Richards, Inc. JDI Class II 1992-07-30
K920738 ACE 100 DEGREES TUBULAR PLATE Ace Orthopedic Manufacturing Co. HRS Class II 1992-07-27
K922196 OSTEO TIBIA NAIL Osteo AG HSB Class II 1992-07-23
K922194 OSTEO STEINMANN PIN Osteo AG HTY Class II 1992-07-23
K922193 OSTEO KIRSCHNER WIRE Osteo AG HTY Class II 1992-07-23
K922195 OSTEO FEMORAL NAIL Osteo AG HSB Class II 1992-07-23
K920430 MODULAR ACETABULAR CUP SYSTEM Smith & Nephew Richards, Inc. JDI Class II 1992-07-21
K921458 TMP MICROPLATING SYSTEM Techmedica, Inc. HRS Class II 1992-07-17
K921786 INTRAMEDULLARY HIP SCREW Smith & Nephew Richards, Inc. KTT Class II 1992-07-17
K921266 NK MEDICAL MICROMETER, MODEL MC001 Nk Biotechnical Engineering Co. KTZ Class I 1992-07-14
K921268 NK DYNA-GRIP SENSOR, MODEL DG001 Nk Biotechnical Engineering Co. LBB Class II 1992-07-14
K910483 MONOTUBE EXTERNAL FIXATION SYSTEM Howmedica Corp. KTT Class II 1992-07-14
K921639 BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM Zimmer, Inc. LPH Class II 1992-07-02
K921622 ALPHATEC COMPRESSION HIP SCREW SYSTEM Alphatec Mfg., Inc. HRS Class II 1992-07-02
K921692 INTEGRATED VIDEO SYSTEM Citation Medical Corp. HRX Class II 1992-07-01
K921139 HEALEY REVISION COMPONENT SYSTEM Biomet, Inc. JDL Class III 1992-07-01
K920639 RX 90 ACETABULAR COMPONENT SYSTEM Biomet, Inc. JDI Class II 1992-06-30
K920640 FULL HEMISPHERE RING-LOC LINER Biomet, Inc. JDI Class II 1992-06-30
K920800 INTEGRATED ENDOSCOPY SYSTEM 1000 Biomet, Inc. HRX Class II 1992-06-30
K921480 OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM Acu-Med, Inc. JDQ Class II 1992-06-26
K921383 PRECISION STRATA TOTAL HIP STEM Howmedica Corp. JDI Class II 1992-06-25
K921384 PCA ACETABULAR INSERT II Howmedica Corp. JDL Class III 1992-06-25
K920608 AMERICA SYSTEM I. Klimov Co. KTT Class II 1992-06-19
K914306 TSRH(TM) LATERAL OFFSET PLATE Sofamor Danek Mfg., Inc. KWP Class II 1992-06-19
K920183 TECH DYNE - HP-2000, SKREEN TEST, RMS-200 Tech Dyne Group LBB Class II 1992-06-15
K915776 KNEE PROSTHESIS DRIVER Kim-Med, Inc. HWR Class I 1992-06-11
K920831 PCA TOTAL HIP SYSTEM (CEMENTLESS USE) Pfizer Hospital Products Group, Inc. LPH Class II 1992-06-10
K921232 KEANE UNI KNEE SYSTEM WITH POROCOAT Depuy, Inc. HSX Class II 1992-06-09
K921873 QUICKANCHOR, MODIFICATION Mitek Surgical Products, Inc. JDR Class II 1992-06-09

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