meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
37
Latest Decision
1983-03-09

Clearances · page 168 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K830255 OSTEOTOMY BONE STAPLE Techmedica, Inc. HXJ Class I 1983-03-09
K830456 STAPLE INSERTER-EXTRACTOR FOR ARTHROS Instrument Makar, Inc. HXJ Class I 1983-03-09
K823724 SPECTRON NECK REPLACEMENT PROSTHESIS Richard'S Medical Equip., Inc. JDI Class II 1983-03-09
K830356 TITANIUM M.E. MULLER TYPE TOTAL HIP Boehringer Mannheim Corp. JDI Class II 1983-03-09
K830455 STAPLES DESIGNED FOR ARTHROSCOPIC SURG Instrument Makar, Inc. JDR Class II 1983-03-09
K830244 TRACTION ACCESSORIES Warm & Form, Orthopedic Materials HST Class I 1983-03-09
K823722 SPECTRON LONG, STRAIGHT FEMORAL PROSTHES Richard'S Medical Equip., Inc. JDI Class II 1983-03-08
K823727 SPECTRON PRIMARY STEM FEMORAL PROSTHES Richard'S Medical Equip., Inc. JDI Class II 1983-03-08
K823848 CRAFTON ARTHROSCOPY PUMP AP-10 Gambro, Inc. HRX Class II 1983-03-08
K830360 3M OSTEOTOMY GUIDE 3M Company HWT Class I 1983-03-01
K830087 INTRAMEDULLARY ROD The Deca Co. HSB Class II 1983-03-01
K830408 FREEMAN/SAMUELSON TOTAL KNEE Depuy, Inc. MBV Class II 1983-02-24
K823832 ESA ARTHROSCOPY CANNULA TRAY Concept, Inc. HRX Class II 1983-02-23
K823482 101 UNIVERSAL ENDOPROSTHESIS Intermedics Orthopedics KWY Class II 1983-02-07
K823420 KINEMATIC II KNEE SYSTEM Howmedica Corp. KRO Class II 1983-02-07
K830154 COLLES FRACTURE FRAME Richard'S Medical Equip., Inc. JEC Class II 1983-02-02
K823499 INTRA-ARTICULAR C02 INSUFFLATOR Surgical Instrument Repair Service Co. HRX Class II 1983-01-28
K823405 ZIMMER GREAT TOE Zimmer, Inc. KWH Class II 1983-01-24
K823728 SPECTRON POLYETHYLENE ACCTUBULAR COMPON Richard'S Medical Equip., Inc. JDI Class II 1983-01-21
K823725 SPECTRON PROTRUSIO CUP Richard'S Medical Equip., Inc. JDI Class II 1983-01-21
K823729 SPECTRON METAL BACK ACETABULAR COMPONENT Richard'S Medical Equip., Inc. JDI Class II 1983-01-21
K823473 POROCOAT MARK IV ELBOW Depuy, Inc. JDB Class II 1983-01-20
K823419 HC 1M METALBACKED ACETABULAR CUP Osteonics Corp. JDI Class II 1983-01-17
K823813 TRACTION ACCESSORIES Danek Medical, Inc. HST Class I 1983-01-14
K822979 CEMENTLESS ZWEYMUELLER HIP ENDOPROTHES Allo Pro Corp. JDI Class II 1983-01-14
K823819 CAST TOE COVER Danek Medical, Inc. LGF Class I 1983-01-14
K823660 UNIVERSAL BUCKS TRACTION Warm & Form, Orthopedic Materials KQZ Class I 1982-12-30
K823548 COMPRESSION HIP SCREW SIDE-PLATE Howmedica Corp. KTT Class II 1982-12-28
K822560 IRRIGATION SET Utah Medical Products, Inc. NBH Class I 1982-12-03
K823115 NATURALYTE BICARBONATE DIALYSATE 4400 Erika, Inc. KRO Class II 1982-12-03
K823395 TRACTION-STEEL FRAMING SYSTEM Orthopedic Systems, Inc. HST Class I 1982-12-03
K823394 WALKING HEEL Orthopedic Systems, Inc. LGF Class I 1982-12-03
K823051 METAL KNEE & HIP PROSTHESIS Zimmer, Inc. KWL Class II 1982-12-03
K823372 OCTAGONAL ALUMINUM FRAMING SYSTEM Orthopedic Systems, Inc. HST Class I 1982-12-03
K823392 FOREARM REDUCTION UNIT Orthopedic Systems, Inc. HST Class I 1982-11-29
K823163 UNIVERSAL BUCKS TRACTION Warm & Form, Orthopedic Materials KQZ Class I 1982-11-10
K822943 ELLISON VITALLIUM FIXATION STAPLE SYS Howmedica Corp. JDR Class II 1982-10-27
K822993 SENATEK American Health Tech., Inc. HST Class I 1982-10-26
K822780 CERVICAL BRACE Jerome Medical JEC Class II 1982-10-06
K822771 101 NEER TYPE SHOULDER Intermedics Orthopedics HSD Class II 1982-10-06
K822583 TOTAL KNEE SYSTEM Richard'S Medical Equip., Inc. MBV Class II 1982-10-04
K821893 ZIMMER METAL BACKED ACETABULAR CUP Zimmer, Inc. JDI Class II 1982-09-14
K822305 ORTHO-LEVEL Frontier Products HTH Class I 1982-08-20
K822321 IOI 32 TM FEMORAL COMPONENT Intermedics Orthopedics KWL Class II 1982-08-20
K821713 POROCOAT LOW PROFILE METAL BACKED CUP Depuy, Inc. JDI Class II 1982-08-20
K821714 POROCOAT STANDARD METAL BACKED CUP Depuy, Inc. JDI Class II 1982-08-20
K822320 KAMPNER FEMORAL COMPONENT Intermedics Orthopedics KWL Class II 1982-08-19
K822109 SHOVEL RETRACTOR Bio-Blitz, Inc. NBH Class I 1982-07-30
K821847 I.M. ARTHROSCOPE Instrument Makar, Inc. HRX Class II 1982-07-22
K821672 PROFLEX Utah Medical Products, Inc. HRX Class II 1982-07-22
K822059 SHOW'RBAG The Healthcare Group Laboratories, Inc. LGF Class I 1982-07-22
K821694 ARTHROLUX ARTHROSCOPE Arthro-Tech, Inc. HRX Class II 1982-07-22
K821695 MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER Micro-Aire Surgical Instruments, Inc. HTT Class I 1982-07-20
K820957 SUFACE REPLACEMENT ELBOW Howmedica Corp. JDB Class II 1982-07-02
K803031 LAURE WRIST IMPLANT Laure Prosthetics, Inc. KWM Class II 1982-06-29
K821476 BARD ENDO LINK INTRACONDYLAR ROTATING C.R. Bard, Inc. KRO Class II 1982-06-23
K821252 HOFFMAN UNIVERSAL FOOT SUPPORT Howmedica Corp. KQZ Class I 1982-06-22
K821522 CERVITRAC TRACTION FRAME & CORD George W. Cottrell HST Class I 1982-06-21
K821631 PINCH GAUGE, 0-301 LBS. Fred Sammons, Inc. HRW Class I 1982-06-11
K820755 THE ORIGINAL LEINBACH PLATFORM TOTAL HIP Allo Pro Corp. KWL Class II 1982-06-10
K821341 IOI METAL BACKED TIBIAL COMPONENT Intermedics Orthopedics HRY Class II 1982-06-03
K821566 ORTHOPEDIC FIXATION DEVICES Howmedica Corp. KTW Class II 1982-06-03
K821343 BDH FEMORAL COMPONENT Intermedics Orthopedics KWL Class II 1982-06-03
K820002 BARD CONTOUR LINK S.K.I. KNEE SYS C.R. Bard, Inc. HRY Class II 1982-05-27
K821340 VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH. Intermedics Orthopedics KRO Class II 1982-05-27
K821359 ARTHROSCOPES & ASSOCIATED INSTRUMENTS Downs Surgical , Ltd. HRX Class II 1982-05-27
K820995 MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS Ludek Optics, Inc. KRO Class II 1982-05-25
K820813 LESSER METATARSAL PHALANG. JOINT PROSTH Sutter Biomedical, Inc. KWH Class II 1982-05-21
K821369 TITANIUM AUFRANC-TURNER ATS HIP SYS Howmedica Corp. JDI Class II 1982-05-21
K820777 MINI-MICRO ARTHROSCOPIC SCAPEL The Anspach Effort, Inc. HRX Class II 1982-05-12
K821066 CONTOUR II LINK SP TOTAL HIP PROSTHESIS C.R. Bard, Inc. JDI Class II 1982-04-29
K820776 CANNUOATED TROCHAR The Anspach Effort, Inc. HRX Class II 1982-04-15
K820852 MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY Serrano Intl. HSB Class II 1982-04-15
K820612 TENSOPLAST SKIN TRACTION KIT Smith & Nephew, Inc. HST Class I 1982-03-31
K820660 A HOOK DRIVER Twin City Surgical, Inc. KWP Class II 1982-03-19
K820659 A CALIPER Twin City Surgical, Inc. KTZ Class I 1982-03-19
K820034 ANTERIOR DISTRACTION SYSTEM Stuart KWQ Class II 1982-03-11
K820351 CAST CUTTER/CAST SAW/INSTRUMENT Black & Decker(Tm) LGH Class I 1982-03-02
K813371 GROSSE AND KEMPF LOCKING NAIL SYS. Howmedica Corp. HSB Class II 1982-03-01
K820275 ARTHROSCOPIC HARPOON The Anspach Effort, Inc. HRX Class II 1982-02-12
K813598 101 TOTAL CONDYLAR KNEE SYSTEM Intermedics Orthopedics JWH Class II 1982-02-10
K820030 HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE Howmedica Corp. HRY Class II 1982-02-05
K820226 UNIVERSALL DRILL GUIDE Ortho Pared Instruments, Inc. HTW Class I 1982-02-04
K820225 MENISCUS EXTRACTOR Ortho Pared Instruments, Inc. HRX Class II 1982-02-04
K813340 HIP PIN The Deca Co. KTW Class II 1982-01-29
K813599 101-32 FEMORAL COMPONENT Intermedics Orthopedics JDL Class III 1982-01-22
K813600 AUFRANC-TURNER TYPE ACETABULAR COMPON Intermedics Orthopedics JDI Class II 1982-01-22
K813000 DISPOSABLE ARTHROSCOPY CANNULA SET Clinical Technology Corp. LXH Class I 1982-01-22
K812904 STERILE ORTHOPEDIC STOCKINETTE Alba Health Care LGF Class I 1982-01-18
K813567 TECHMEDIA BONE STAPLE Techmedica, Inc. JDR Class II 1982-01-12
K813554 ACE/KYLE CAPTURED HIP SCREW Ace Orthopedic Manufacturing Co. KTT Class II 1982-01-12
K812322 ARIZONA RADIO CAPITELLAR TOTAL ELBOW Zimmer, Inc. JDB Class II 1982-01-04
K812778 THE TELOS EQUIPMENT The Telos Co. KQW Class I 1981-12-08
K813017 NECKTRAC Lossing Orthopedic, Inc. HST Class I 1981-11-25
K813067 SPINAL WRENCH Twin City Surgical, Inc. HXC Class I 1981-11-24
K813016 ZEE TRACTION SPLINT Zee Medical Products Co., Inc. HST Class I 1981-11-24
K812908 ELECTRO-GONIOMETER Chattanooga Group, Inc. KQX Class I 1981-11-24
K813089 CEMENT RING Biomet, Inc. JDI Class II 1981-11-20
K812899 MED-EX Chattanooga Group, Inc. LBB Class II 1981-11-06
K812779 EXTENSIONS-LUSATZTISCH The Telos Co. HST Class I 1981-10-26

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