meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
29
Latest Decision
1991-12-19

Clearances · page 154 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K914282 NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER Surgical Dynamics, Inc. HRX Class II 1991-12-19
K913145 NUCLEOTOME TISSUE ASPIRATOR/CUTTER Surgical Dynamics, Inc. HRX Class II 1991-12-19
K914269 EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO Scientific Spinal , Ltd. KWP Class II 1991-12-18
K913634 APR II HIP SYSTEM Intermedics Orthopedics JDI Class II 1991-12-16
K914230 AXIOM TOTAL KNEE SYSTEM, ALL POLY TIBIAL TRAY Orthomet, Inc. JWH Class II 1991-12-16
K914061 NK RANGE OF MOTION SENSOR, MODEL RM002 Nk Biotechnical Engineering Co. KQX Class I 1991-12-09
K914060 RANGE OF MOTION SENSOR, MODEL RM001 Nk Biotechnical Engineering Co. KQX Class I 1991-12-09
K914059 NK DEVIATION SENSOR, MODEL DV001 Nk Biotechnical Engineering Co. LBB Class II 1991-12-09
K912099 3M FLUID CONTROL SYSTEM SMALL JOINT COPS CANNULA 3M Company HRX Class II 1991-12-09
K914062 NK DEXTERITLY BOARD, MODEL BX001 Nk Biotechnical Engineering Co. KQX Class I 1991-12-09
K914054 NK GRASP SENSOR, MODEL GR001 Nk Biotechnical Engineering Co. LBB Class II 1991-12-09
K914693 DEPUY (NITINO) GUIDE WIRE Depuy, Inc. JDQ Class II 1991-12-09
K914055 PINCH SENSOR, MODEL PF001 Nk Biotechnical Engineering Co. LBB Class II 1991-12-09
K914057 NK PINCH SENSOR, MODEL PA001 Nk Biotechnical Engineering Co. LBB Class II 1991-12-09
K913916 HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT Smith & Nephew Richards, Inc. MEH Class II 1991-12-09
K914056 NK PINCH SENSOR, MODEL PF002 Nk Biotechnical Engineering Co. LBB Class II 1991-12-09
K914058 NK PINCH SENSOR, MODEL PA002 Nk Biotechnical Engineering Co. LBB Class II 1991-12-06
K914004 ALPHATEC CANNULATED BONE SCREWS Alphatec Mfg., Inc. HWC Class II 1991-12-05
K914237 KINAMED CTN STEM Kinamed, Inc. LZO Class II 1991-12-05
K914000 GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE Depuy, Inc. KWT Class II 1991-12-04
K913355 LUHR PAN FIXATION SYSTEM Howmedica Corp. HRS Class II 1991-12-02
K914546 ANGLED BLADE PLATE Synthes (Usa) KTW Class II 1991-11-29
K913874 INFINITY(TM) MICROTAPER HIP SYSTEM Dow Corning Wright JDI Class II 1991-11-27
K912641 BIOPRO ZIRALLOY MODULAR FEMORAL HEADS Biopro, Inc. LZO Class II 1991-11-27
K912598 ACE CORTICAL BONE SCREW Ace Medical Co. HWC Class II 1991-11-27
K913812 OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES Osteonics Corp. JDI Class II 1991-11-22
K913633 TOTAL HIP PROSTHESIS- FEMORAL COMPONENTS Intermedics Orthopedics LZO Class II 1991-11-22
K911378 TOWNLEY GREAT TOE JOINT Biopro, Inc. KWD Class II 1991-11-22
K913269 OSTEO BONE SCREWS Fred C. Bryson HWC Class II 1991-11-22
K912021 MAKAR MINI CANNULATED CANCELLOUS SCREWS Instrument Makar, Inc. HWC Class II 1991-11-22
K914858 ACE OPEN-BACK HALO RING Ace Medical Co. JEC Class II 1991-11-21
K913735 SONGER(TM) CABLE SYSTEM Danek Medical, Inc. JDQ Class II 1991-11-18
K911837 SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE Acufex Microsurgical, Inc. JDR Class II 1991-11-15
K913649 MODULAR CALCAR REPLACEMENT Zimmer, Inc. JDI Class II 1991-11-13
K913632 BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM Kirschner Medical Corp. KWY Class II 1991-11-13
K913616 LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP Implant Technology, Inc. JDI Class II 1991-11-07
K914472 SPIKED WASHER Synthes (Usa) HTN Class II 1991-11-07
K911974 PGK STEREOTACTIC DEVICE Northern Virginia Radiology and Nuclear Medicine HRX Class II 1991-11-05
K913415 AESCULAP TITANIUM BONE SCREWS Aesculap, Inc. HWC Class II 1991-10-29
K911972 FREEMAN-SAMUELSON MODULAR TOTAL KNEE REPLACEMENT Intermedics Orthopedics JWH Class II 1991-10-25
K904520 RAY SACRAL FIXATION SYSTEM Danek Medical, Inc. KWP Class II 1991-10-25
K911307 CROSSLINK PLATE Danek Medical, Inc. KWP Class II 1991-10-24
K914439 P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL Johnson & Johnson Orthopaedics, Inc. HSX Class II 1991-10-23
K913282 LIMA RPS SHOULDER Turnkey Intergration USA, Inc. HSD Class II 1991-10-21
K913246 HYBRID FIT TOTAL HIP SYSTEM Kirschner Medical Corp. JDI Class II 1991-10-18
K912894 AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERT Orthomet, Inc. JWH Class II 1991-10-18
K913271 OSTEO BONE PLATED Fred C. Bryson HRS Class II 1991-10-17
K913461 FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM Neoligaments, Ltd. JDR Class II 1991-10-15
K912710 TRUE/FLEX TIBIAL RODS WITH CAP Applied Osteo Systems, Inc. HSB Class II 1991-10-15
K912369 HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT) Biomet, Inc. MEH Class II 1991-10-11
K913060 NATURAL POROUS HIP SYSTEM Intermedics Orthopedics JDI Class II 1991-10-11
K913188 KINEMAX PLUS TIBIAL INSERT Howmedica Corp. JWH Class II 1991-10-11
K912370 HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES) Biomet, Inc. MEH Class II 1991-10-11
K913208 APR II NON-POROUS HIP STEM Intermedics Orthopedics JDI Class II 1991-10-11
K913028 ARTHRO-FLOW IRRIGATION 2 SYSTEM Davol, Inc. HRX Class II 1991-10-10
K912957 CONCEPT MICROMILL Concept, Inc. HRX Class II 1991-10-04
K910681 SIMMONS PLATING SYSTEM Smith & Nephew Richards, Inc. KWQ Class II 1991-10-04
K912922 DIMENSION-HA HIP PROSTHESIS Kirschner Medical Corp. MEH Class II 1991-10-04
K912452 HA MCCUTCHEN SLT HIP SYSTEM Dow Corning Wright MEH Class II 1991-10-04
K913930 FIXATION DEVICES AND BONE PLATE John M. Rayhack HRS Class II 1991-10-04
K911768 AMSET(TM) BONE SCREW Advanced Med/Surg, Inc. HWC Class II 1991-10-04
K912931 ITM SONIC SURGERY SYSTEM Buckman Co., Inc. JDX Class II 1991-10-03
K912593 MODULAR HIP SYSTEM Smith & Nephew Richards, Inc. JDI Class II 1991-10-02
K912916 APR COLLAR SPACER Intermedics Orthopedics JDI Class II 1991-09-27
K913079 02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360 Lucas Sensing Systems, Inc. KQX Class I 1991-09-25
K912932 SYNTHES MAXILLOFACIAL TITANIUM MICRO SET Synthes (Usa) HRS Class II 1991-09-25
K911296 OPTICAL CATHETER ARTHROSCOPE Medical Dynamics, Inc. HRX Class II 1991-09-24
K912843 FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE Flexmedics HXB Class I 1991-09-24
K912420 ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM Scientific Research HSB Class II 1991-09-23
K911375 G-PIN Dr.M.A.Galluzzo HTY Class II 1991-09-23
K913347 PALMER ARCH SUPPRESSOR Smith & Nephew Dyonics, Inc. HRX Class II 1991-09-18
K912663 NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT Intermedics Orthopedics JWH Class II 1991-09-16
K911379 DANEK SACRAL HOOK, MODIFICATION Danek Medical, Inc. KWP Class II 1991-09-11
K911306 T-BOLT AND NUT Danek Medical, Inc. HTN Class II 1991-09-10
K910940 ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY Depuy, Inc. JWH Class II 1991-09-10
K912936 MAY HUMERUS PLATES Turnkey Intergration USA, Inc. HRS Class II 1991-09-06
K911319 TSRH OPEN HEAD BONE SCREW Danek Medical, Inc. KWP Class II 1991-09-06
K913289 MASTERPIECES(TM)/MICRO/MINI SYSTEMS Storz Instrument Co. HRS Class II 1991-09-05
K904446 CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.) Acromed Corp. KWQ Class II 1991-09-05
K912526 GS-220 HAND IMPAIRMENT EVALUATION SYSTEM J-Tech, Inc. LBB Class II 1991-09-05
K912190 STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST Stryker Corp. JDZ Class I 1991-08-29
K912263 HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC Zimmer, Inc. MEH Class II 1991-08-29
K912453 INTELIJET TM FLUID MANAGEMENT SYSTEM Smith & Nephew Dyonics, Inc. HRX Class II 1991-08-26
K910968 P.F.C. UNICONDYLAR KNEE SYSTEM Johnson & Johnson Orthopaedics, Inc. HRY Class II 1991-08-26
K910193 HUENE FIXATION SCREW Acu-Med, Inc. HWC Class II 1991-08-23
K912426 UHMWP ACETABULAR COMPONENT Howmedica Corp. JDI Class II 1991-08-21
K912266 MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP Orothmet, Inc. JWH Class II 1991-08-20
K912245 AGC REVISION KNEE PROTHESIS Biomet, Inc. JWH Class II 1991-08-19
K912206 MICRO-AIRE ARTHROS SURG BLADES-VARIOUS CO PROD NO. Microaire HRX Class II 1991-08-16
K911728 OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C Osteonics Corp. MEH Class II 1991-08-16
K912654 OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP Osteonics Corp. MEH Class II 1991-08-16
K912205 MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO Microaire HRX Class II 1991-08-16
K912162 INTRAMEDULLARY HIP SCREW, MODIFICATION Smith & Nephew Richards, Inc. KTT Class II 1991-08-14
K912147 OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP Osteonics Corp. JWH Class II 1991-08-13
K912295 KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL Kinamed, Inc. LZO Class II 1991-08-12
K912871 INSIDE JOB 3M Health Care, Ltd. HRX Class II 1991-08-09
K910482 ALTA CHANNEL PLATE CONNECTOR Howmedica Corp. HRS Class II 1991-07-30
K911982 BONE NAIL, KUNTSCHER International Hospital Supply Co. HSD Class II 1991-07-26
K911890 OSTEONICS(R) PRT HIP STEM SERIES Osteonics Corp. JDI Class II 1991-07-26
K910877 FINN KNEE PROSTHESIS Biomet, Inc. KRO Class II 1991-07-26

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