meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
26
Latest Decision
1992-06-08

Clearances · page 153 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K920193 OMNIFLEX M-HA HIP STEM SERIES Stryker Corp. KWL Class II 1992-06-08
K920231 OMNIFIT M-HA HIP STEM SERIES Stryker Corp. KWL Class II 1992-06-08
K914963 SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET Smith & Nephew Dyonics, Inc. HRX Class II 1992-06-04
K921402 SURGICAL INSTRUMENT, DISPOSABLE Macro Medical, Inc. LXH Class I 1992-06-04
K921642 AMSEN DOUBLE-ENDED FORAMINAL PROBE Advanced Med/Surg, Inc. LXH Class I 1992-06-03
K921644 AMSEN HOCKEY STICK CHISEL Advanced Med/Surg, Inc. LXH Class I 1992-06-03
K921643 AMSEN POSTERIOR DISC EVACUATOR Advanced Med/Surg, Inc. LXH Class I 1992-06-03
K921645 AMSEN SPINE IMPACTOR INSTRUMENTS Advanced Med/Surg, Inc. LXH Class I 1992-06-03
K914998 MICROAIRE(R) FACIAL BONE PLATING SYSTEM Micro Surgical Instruments Corp. HRS Class II 1992-06-02
K915617 LSF HA COATED FEMORAL HIP Implant Technology, Inc. MEH Class II 1992-05-28
K920868 ACETABULAR DOME AND SCREW HOLE PLUGS Osteonics Corp. JDL Class III 1992-05-26
K920690 NOROTRACK 360 INCLINOMETER Noromed, Inc. KQX Class I 1992-05-20
K920756 FELDMUHLE CERAMIC HEAD Link America, Inc. LZO Class II 1992-05-18
K920577 HOWEDICA ZIRCONIA FEMORAL HEAD Howmedica Corp. LZO Class II 1992-05-15
K914565 OSTEONICS 7000 POSTERIOR STAB. TOTAL KNEE FEM. COM Osteonics Corp. JWH Class II 1992-05-15
K920524 OSTEONICS 7000 SERIES TOTAL KNEE BONE AUGMENTATION Osteonics Corp. JWH Class II 1992-05-15
K914966 TSRH CENTRAL POST HOOKS Sofamor Danek Mfg., Inc. KWP Class II 1992-05-12
K920102 THE SELBY SYSTEM Advanced Spine Fixation Systems, Inc. KWP Class II 1992-05-05
K912640 CONCEPT ENDOSTEAL FIXATION DEVICE Concept, Inc. HWC Class II 1992-05-01
K920213 MITEK ANCHOR, MITEK ANCHOR II Mitek Surgical Products, Inc. JDR Class II 1992-05-01
K914362 TOP CERVICAL SPINE PLATES & TITANIUM BONE SCREWS Acorn Group, Inc. KWQ Class II 1992-04-29
K914804 RADIUS OSTEOTOMY PLATES Link America, Inc. HRS Class II 1992-04-29
K914803 SCHWABE RADIUS PLATES Link America, Inc. HRS Class II 1992-04-28
K920598 TRUE/FLEX HUMERUS CAP Applied Osteo Systems, Inc. HSB Class II 1992-04-28
K920286 DEPUY TOTAL HIP BALLS - ION IMPLANTATION Depuy, Inc. JDI Class II 1992-04-21
K920250 OSTEONICS MICROSURFACED CDH HIP STEM Stryker Corp. JDI Class II 1992-04-20
K920161 BIOMET NTS FEMORAL COMPONENTS Biomet, Inc. JDI Class II 1992-04-13
K920116 PWB LUMBOSACRAL SPINE SYSTEM Cross Medical Products, Inc. KWP Class II 1992-04-10
K920149 OSTEO EX-FI-RE Osteo AG JEC Class II 1992-04-09
K920201 TITANIUM ALLOY SONGER CABLE SYSTEM Sofamor Danek Mfg., Inc. JDQ Class II 1992-04-08
K910664 MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN. Medimix Products, Inc. LWJ Class II 1992-04-01
K920021 LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP Implant Technology, Inc. JDI Class II 1992-03-25
K911663 CROSSLINK SYSTEM Synthes (Usa) KWP Class II 1992-03-23
K915868 PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT Orthomet, Inc. KWL Class II 1992-03-23
K920317 S-ROM LF FEMORAL HEAD Joint Medical Products Corp. JDI Class II 1992-03-19
K915721 MODEL AR-6300 INFUSION PUMP Arthrex, Inc. HRX Class II 1992-03-19
K920034 DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC Pfizer Hospital Products Group, Inc. JWH Class II 1992-03-18
K915800 BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN Bremer Medical, Inc. JEC Class II 1992-03-16
K920003 DRG CEMETED STEM Intermedics Orthopedics JDI Class II 1992-03-13
K913730 AESCULAP TITANIUM BONE PLATES Aesculap, Inc. KWQ Class II 1992-03-12
K915596 BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD Biomet, Inc. KWT Class II 1992-03-11
K915548 IONGUARD TITANIUM MODULAR HEADS Biomet, Inc. LZY Class II 1992-03-10
K913401 SUCTION CONTROL FOOTSWITCH WITH SPEED CONTROL Smith & Nephew Dyonics, Inc. HRX Class II 1992-03-06
K915795 PERFECTA PDA TOTAL HIP SYSTEM Orthomet, Inc. JDI Class II 1992-03-04
K915435 INTERLOCKING TIBIAL NAILING SYSTEM Stryker Corp. HSB Class II 1992-03-02
K915448 CORTICAL BONE SCREW Dow Corning Wright HWC Class II 1992-02-28
K915315 AAP BONE PLATE Aap International, Ltd. HRS Class II 1992-02-20
K915310 KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL Kinamed, Inc. LZO Class II 1992-02-19
K915309 KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL Kinamed, Inc. LZO Class II 1992-02-19
K914072 CONTINUUM KNEE SYSTEM (CKS) Techmedica, Inc. JWH Class II 1992-02-18
K914453 UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL Synthes (Usa) JDS Class II 1992-02-18
K914559 SMALL JOINT SYSTEM Smith & Nephew Dyonics, Inc. HRX Class II 1992-02-18
K914371 UNIVERSAL FEMORAL NAIL Synthes (Usa) JDS Class II 1992-02-18
K915186 7000 SERIES TOTAL KNEE PATELLAR COMPONENTS Osteonics Corp. JWH Class II 1992-02-14
K901692 DANEK SPINALSCOPE Danek Medical, Inc. HRX Class II 1992-02-14
K915316 AAP BONE SCREW Aap International, Ltd. HWC Class II 1992-02-14
K915192 7000 SERIES MODULAR TIBIAL COMPONENTS Osteonics Corp. JWH Class II 1992-02-14
K915613 BONE SCREW 3.5 MM Acu Med, Inc. HWC Class II 1992-02-13
K915132 MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM Biomet, Inc. JWH Class II 1992-02-11
K915216 SOLUTION SYSTEM CUP Depuy, Inc. JDI Class II 1992-02-11
K915124 UNIVERSAL COMPRESION SCREW Howmedica Corp. HWC Class II 1992-02-11
K915259 FX-CABLELOK SYSTEM, MODIFICATION Biodynamic Technologies, Inc. JDQ Class II 1992-02-07
K914843 KINAMED ATH-HA & ATH-HA LONG TOTAL HIP Kinamed, Inc. MEH Class II 1992-02-03
K910874 THORACIC ANTERIOR SPINAL FIXATION PLATE Terray Manufacturing, Inc. KWQ Class II 1992-02-03
K915350 HYDROXYAPATITE INFINITY TROCHANTERIC MODULE Dow Corning Wright MEH Class II 1992-02-03
K905023 AMSET LOCKING PLATE SYSTEM Advanced Med/Surg, Inc. KWQ Class II 1992-01-31
K915240 NATURAL-KNEE TIBIAL AND FEMORAL SPACERS Intermedics Orthopedics HSX Class II 1992-01-31
K915184 HOWMEDICA ALUMINA FEMORAL HEAD Pfizer Hospital Products Group, Inc. LZO Class II 1992-01-31
K901507 MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS) Kirschner Medical Corp. KWQ Class II 1992-01-28
K913708 VENUS HIP Turnkey Intergration USA, Inc. LWJ Class II 1992-01-27
K914169 WHITESIDE ORTHOLOC MOD.TIBIAL AUGMENTATION COMP Dow Corning Wright JWH Class II 1992-01-27
K913210 M. KUROSAKA(TM) FIXATION SCREW Depuy, Inc. HWC Class II 1992-01-24
K904243 TSRH VARIABLE ANGLE SACRAL SCREW Danek Medical, Inc. KWP Class II 1992-01-22
K920024 RIHARDS TITANIUM HALF PIN Smith & Nephew Richards, Inc. KTT Class II 1992-01-21
K913949 TRUE/FLEX HUMERUS, ULNA & RADIUS INTRAMED RODS SYS Applied Osteo Systems, Inc. HSB Class II 1992-01-17
K915818 SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE Synthes (Usa) HRS Class II 1992-01-17
K913561 LUQUE SEGMENTAL SPINAL INSTRUMENTATION Zimmer, Inc. KWP Class II 1992-01-16
K913420 ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF Biomet, Inc. LZO Class II 1992-01-16
K914695 GLOBAL TOTAL SHOULDER Depuy, Inc. KWT Class II 1992-01-16
K915581 CODMAN SOF'WIRE (TM) KIT Codman & Shurtleff, Inc. JDQ Class II 1992-01-16
K915692 CANNULATED DRILL BIT W. L. Gore & Associates, Inc. HTW Class I 1992-01-16
K914558 TRAUMAFIX (TM) EXTERNAL FIXATOR Synthes (Usa) KTT Class II 1992-01-16
K910986 HOFFMANN DYNAMIC WRIST FIXATOR Howmedica Corp. KTT Class II 1992-01-16
K914676 ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER Zimmer, Inc. LZO Class II 1992-01-13
K910976 OREGON FIXATION SCREW Acu Med, Inc. HWC Class II 1992-01-13
K914574 EXACTECH CERAMIC FEMORAL HEAD COMPONENT Exactech, Inc. LZO Class II 1992-01-13
K912930 INTERLOCKING FEMORAL NAILING SYSTEM Stryker Corp. HSB Class II 1992-01-13
K914343 TI-FIT FEMORAL COMPONENT Smith & Nephew Richards, Inc. LWJ Class II 1992-01-13
K914812 K-CAP-E, STERILE Westcon Orthopedics, Inc. LYT Class II 1992-01-09
K914436 CLINICAL HANDMASTER SYSTEM OR CHMS Exos Medical Products LBB Class II 1992-01-02
K911802 PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP Biomet, Inc. JDI Class II 1992-01-02
K914374 OSTEO CERCLAGE WIRE Osteo AG JDQ Class II 1991-12-30
K912713 S-ROM ZT HA PROXIMAL FEMORAL SLEEVE Joint Medical Products Corp. MEH Class II 1991-12-30
K913492 KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM Kirschner Medical Corp. JWH Class II 1991-12-27
K912735 GENESIS UNICOMPARTMENTAL KNEE SYSTEM Smith & Nephew Richards, Inc. HSX Class II 1991-12-27
K912985 LIMA 28MM CERAMIC HEAD, MODIFICATION Turnkey Intergration USA, Inc. LZO Class II 1991-12-24
K913231 S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD Joint Medical Products Corp. JDI Class II 1991-12-20
K914406 PT II DISTAL CEMENT SPACER Osteonics Corp. JDI Class II 1991-12-20
K912712 BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS Biomet, Inc. JDI Class II 1991-12-20
K915187 CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW Techmedica, Inc. HWC Class II 1991-12-19

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