meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
51
Latest Decision
1980-08-04

Clearances · page 170 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K801157 WEBER-MAYO WRIST Depuy, Inc. KWM Class II 1980-08-04
K801716 BK-7505 RADIOPAQUE GONIOMETER, 8 Fred Sammons, Inc. KQW Class I 1980-08-04
K801715 BK-7497 BULB DYNAMOMETER Fred Sammons, Inc. KQW Class I 1980-08-04
K801388 OH-HARRIS Johnson & Johnson Professionals, Inc. KIH Class I 1980-07-28
K801345 KAMPNER HINGED TOE PROSTHESIS Biomedics KWH Class II 1980-07-08
K801094 SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL Dow Corning Corp. Healthcare Industries Materials KWH Class II 1980-06-09
K801327 THE EXTRACTOR I TM The Anspach Effort, Inc. HWB Class I 1980-06-09
K801010 KIRSCHNER WIRE American Safety Equipment Corp. HSB Class II 1980-05-20
K801080 EDWARDS ROD SLEEVES Zimmer, Inc. KWP Class II 1980-05-20
K801120 DUNN ANTERIOR DISTRACTION SYSTEM Zimmer, Inc. KWP Class II 1980-05-20
K801006 CHARNLEY DESIGN HIP PROSTHESIS Colmed, Ltd. JDG Class II 1980-05-20
K800721 GENERAL UTILITY SURG. SCISSORS #460180- Edward Weck, Inc. HRR Class I 1980-05-08
K792089 THE HOWMEDICA KINEMATIC KNEE SYSTEM Howmedica Corp. JWH Class II 1980-05-06
K800894 DUPUY CEMENT RESTRICTOR TRIALS & INSTR. Depuy, Inc. JDI Class II 1980-05-02
K800898 SILASTIC BONE PLUG H.P.(CEMENT RESTRICT) Dow Corning Corp. Healthcare Industries Materials JDS Class II 1980-05-02
K800487 3M TITANIUM ALLOY TOTAL HIP SYSTEM 32MM 3M Company JDI Class II 1980-04-29
K800640 MEDICAL COMPARTMENT KNEE PROSTHESIS Dow Corning Wright HSX Class II 1980-04-21
K800800 PATELLAR COMPONENT FOR LUBINUS PATELLAR Waldemar Link GmbH & Co. KG HTG Class II 1980-04-21
K800806 I.C.S. MINI & SMALL FRAGMENT SET Howmedica Corp. HRS Class II 1980-04-21
K800501 PFIZER/AS&E 0450 LOCALIZER Pfizer Medical Systems, Inc. JDX Class II 1980-04-10
K800732 MENISCOTOME Stainless Mfg., Inc. HXP Class I 1980-04-08
K800729 PROBE Stainless Mfg., Inc. HXB Class I 1980-04-08
K800731 MENISCAL SAW Stainless Mfg., Inc. HXP Class I 1980-04-08
K800730 RETROGRADE KNIFE Stainless Mfg., Inc. HXP Class I 1980-04-08
K800733 DOUBLE-EDGE CURETTE Stainless Mfg., Inc. HXP Class I 1980-04-08
K800502 ADDITIONAL COMPONENTS KRONNER COMPRES Richard F. Kronner, M.D. HRS Class II 1980-04-02
K800530 SCHLEIN TRI-SURFACE ANKLE Orthopedic Equipment Co., Inc. HSN Class II 1980-04-02
K800494 NEW JERSEY HEMIARTHROPLASTY SHOLDER PROS Depuy, Inc. HSD Class II 1980-03-18
K800363 PARKE-DAVIS TOTAL KNEE PROSTHESIS Warner-Lambert Co. KTZ Class I 1980-03-10
K800444 GOLDEN RETRIEVERS OR SILVER RETRIEVERS Instrument Makar, Inc. HXB Class I 1980-03-05
K792670 SMITH SUBTALAR PEG Dow Corning Wright LXH Class I 1980-02-22
K800274 ACUFEX PROBES Acufex Microsurgical, Inc. HXB Class I 1980-02-19
K800142 FUSON BONE PLUG, RADIOPAQUE Zimmer, Inc. JDS Class II 1980-02-19
K800144 FEMORAL CEMENT RESTRICTOR Biomet, Inc. JDS Class II 1980-02-19
K800207 UHR UNIVERSAL6HIP REPLACEMENT Osteonics Corp. KWL Class II 1980-02-11
K800184 OXFORD EXTERNAL FIXATION SYSTEM Downs Surgical , Ltd. JEC Class II 1980-02-11
K792619 RMC KNEE METAL SHOE TIBIAL COMPONENTS Richard'S Medical Equip., Inc. HRY Class II 1980-02-05
K792650 HAMAS PRECENTERED TOTAL WRIST Zimmer, Inc. JWJ Class II 1980-01-28
K800051 HEXCEL FEMORAL COMPONENT HIP PROSTHESIS Hexcel Medical JDG Class II 1980-01-28
K800050 ANITOMIC TOTAL HIP SYSTEM Hexcel Medical JDG Class II 1980-01-24
K792329 BIOPHASE IMPLANT MATERIAL Richard'S Medical Equip., Inc. JDG Class II 1980-01-23
K792325 LIVERPOOL KNEE PROSTHESIS Downs Surgical , Ltd. HRY Class II 1980-01-21
K792687 ASPERGILLUS SP., ANTIGEN Meridian Diagnostics, Inc. JWI Class II 1980-01-17
K792561 MINI-H-FIXATION Geny Medical, Inc. JEC Class II 1979-12-19
K792205 SEIDEL INTRAMEDULLARY PLUG Howmedica Corp. HWC Class II 1979-12-06
K792291 SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES Synthes (Usa) KTW Class II 1979-12-06
K792352 SYNTHES CERVICAL VERTABRAE PLATES DePuy Synthes KWQ Class II 1979-12-06
K792200 TILLMAN HIP RESURFACING REPLACEMT PROS. Waldemar Link GmbH & Co. KG KXA Class II 1979-12-05
K792204 HOWMEDICA COMPRESSION STAPLE SYSTEM Howmedica Corp. JDR Class II 1979-12-05
K792240 POLYCENTRIC TOTAL KNEE METAL TIBIAL Howmedica Corp. HSX Class II 1979-12-05
K792186 HOWMEDICA MIX-KIT II Howmedica Corp. JDZ Class I 1979-12-05
K792203 CURVED KUNTSCHER INTRAMEDULLARY NAIL Howmedica Corp. HSB Class II 1979-12-05
K792253 ARICULATED TENSION DEVICE SYNTHES TEN Synthes (Usa) HWN Class I 1979-12-05
K792248 TAYLOR TRACTION CORD Taylor Medical Equipment HST Class I 1979-11-30
K792181 3M HS 22 FEMORAL COMPONENT 3M Company KWL Class II 1979-11-15
K791823 3M UPF PROXIMAL FEMUR REPLACEMENT SYSTEM 3M Company KWY Class II 1979-10-30
K792022 HERBERT BONE SCREW Zimmer, Inc. HWC Class II 1979-10-26
K791919 BAC JAC Haggin Industries, Inc. HST Class I 1979-10-04
K791960 ROTH-KENNEDY PASSER 3M Company HWQ Class I 1979-10-04
K791548 REXTON HS(HEARING SYSTEM) Argosy Intl. (Usa), Inc. HSD Class II 1979-09-28
K791619 DYNAMIC HIP SCREW Synthes (Usa) KTT Class II 1979-08-28
K791396 MEDI-TRAK PORTABLE TRACTION DEVICE Medicorp, Inc. HST Class I 1979-08-16
K791466 ACE EXTERNAL BONE CLAMP PART #S11 Ace Orthopedic Manufacturing Co. JEC Class II 1979-08-16
K790774 LODA WRIST PROSTHESIS Depuy, Inc. KWM Class II 1979-08-03
K790996 C.C.F. FEMORAL DEBRIDEMENT PROBE Depuy, Inc. HTO Class I 1979-06-27
K790987 ZIMMER R TOTAL SHOULDER II Zimmer, Inc. KWT Class II 1979-06-22
K790793 AMC R METACARPAL COMPONENT Howmedica Corp. KWN Class II 1979-06-22
K791073 WRENCH Truth, Inc. HXC Class I 1979-06-20
K791021 MUSCLE TESTING GUN The Orthodyn Co. HRW Class I 1979-06-15
K791009 SANTA CASA DISTRACTOR Depuy, Inc. KWP Class II 1979-06-11
K790941 D.T.T. LOCK SCREW INSERTER Depuy, Inc. KWQ Class II 1979-05-23
K790877 BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO Stackhouse Assoc. JDY Class I 1979-05-23
K790762 PLATFORM TCCK TOTAL KNEE Biomet, Inc. HRY Class II 1979-05-14
K790219 PROTHESIS, RETAINED GEOMETRIC KNEE Zimmer, Inc. JWH Class II 1979-05-08
K790729 OCTAGONAL ALUMINUM FRAMING SYSTEM Orthopedic Systems, Inc. HST Class I 1979-05-01
K790465 KNEE COMPRESSION HOOK SYSTEM Zimmer, Inc. KWP Class II 1979-04-12
K790501 PEDIATRIC OSTEOTOMY SYSTEM Howmedica Corp. KTT Class II 1979-04-10
K790508 TRAPEZIO-METACARPAL JOINT SPACER Scientific Data Systems Israel, Ltd. KYI Class II 1979-04-10
K781971 KNEE SYSTEM, QUADRAXIAL CONSTRAINED Hexcel Medical KRO Class II 1979-04-04
K790488 INTERPLANTA SP TOTAL HIP PROSTHESIS Waldemar Link GmbH & Co. KG JDI Class II 1979-03-28
K790274 BG PROXIMAL FEMUR Howmedica Corp. JDL Class III 1979-03-26
K782061 SPINAL SURGERY INSTRUMENTATION Stuart Drug & Surgical Supply, Inc. KWQ Class II 1979-03-21
K790404 DTT SYSTEM Depuy, Inc. KWQ Class II 1979-03-21
K790302 PRESSURE MONITOR, MODEL 212 Zatek HRW Class I 1979-03-21
K790348 ANAMETRIC TIBIAL COMPONENT METAL TRAY Howmedica Corp. HRY Class II 1979-03-06
K790350 POSTERIOR CRUCIATE CONDYLAR TIBIAL Howmedica Corp. HRY Class II 1979-03-06
K790349 TOTAL CONDYLAR KNEE PROSTHESIS Howmedica Corp. HRY Class II 1979-03-06
K790307 FLEXIBLE REAMER, GUIDE WIRE SYSTEM 3M Company HTO Class I 1979-02-22
K781380 MARNE M.T.P.J. ORTHOPEDIC IMPLANT Farah , Ltd. KYJ Class II 1979-02-21
K790275 GUN, EXETER CEMENT Howmedica Corp. KIH Class I 1979-02-21
K790262 UNIVERSAL EXTERNAL FIXATION ASSEMBLY Zimmer, Inc. JEC Class II 1979-02-13
K790238 TRANSVERSE TRACTION ASSEMBLY Zimmer, Inc. KWP Class II 1979-02-12
K781870 IMPLANT, H.P. CONDYLAR Dow Corning Corp. Healthcare Industries Materials KWD Class II 1979-02-09
K790125 ULNAR HEAD PROTHESIS Cutter Laboratories, Inc. KXE Class II 1979-02-08
K771988 VERTETRAC Ballert Orthopedic Corp. HST Class I 1979-02-01
K782123 MULTIPLICITY OF PRODUCTS Depuy, Inc. HRS Class II 1979-01-10
K781762 COMPRESSION HIP SCREW SYSTEM Howmedica Corp. KTW Class II 1978-12-20
K781955 GUN, CEMENT Depuy, Inc. KIH Class I 1978-12-04
K781943 TENDON ROD MODEL OR41PO3-6 Holter-Hausner Intl. HXA Class II 1978-12-04
K781756 SILASTIC H.P. TRAPEXIAL IMPLANT Dow Corning Corp. Healthcare Industries Materials KYI Class II 1978-11-15

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