meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
40
Latest Decision
1984-03-23

Clearances · page 167 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K840617 MASTERFOOT CAST HEEL Seton Products, Inc. LGF Class I 1984-03-23
K840423 HARRINGTON-TYPE INSTRU-SCOLIOSIS Link America, Inc. KWP Class II 1984-03-23
K833599 MODIFIED HPS HIP PROSTHESIS Depuy, Inc. KWL Class II 1984-03-19
K834108 NEEDLE BENDER TX8225 Today'S Machining & Design, Inc. LXH Class I 1984-03-12
K834146 ANTHROSCOPY SYSTEM Cabot Medical Corp. HRX Class II 1984-03-08
K833404 BDH BIPOLAR FEMORAL COMPONENT A3 Carbomedics, Inc. KWY Class II 1984-03-02
K833439 POROCOAT NEB TOTAL HIP SYSTEM Depuy, Inc. LPH Class II 1984-03-02
K833943 MENISCAL SUTURING SYSTEM Dyonics, Inc. LXH Class I 1984-02-27
K840150 TOTAL HIP FEMORAL COMPONENT Advanced Biosearch Assn. JDI Class II 1984-02-27
K834370 MULHOLLAN ARTHROSCOPIC NEEDLE CARRIER Acufex Microsurgical, Inc. LXH Class I 1984-02-27
K834369 CRANE MENISCAL SUTURE SET Acufex Microsurgical, Inc. LXH Class I 1984-02-27
K840357 SSA HIP PROSTHESIS Dow Corning Corp. Healthcare Industries Materials JDI Class II 1984-02-17
K833363 CLOUTIER II FIBER METAL TOTAL KNEE Zimmer, Inc. JWH Class II 1984-02-13
K834298 UNICONDYLAR FIBER METAL KNEE Zimmer, Inc. HRY Class II 1984-02-13
K833952 FIXATION PINS ETHICON, Inc. HTY Class II 1984-02-10
K840046 PRESSURIZING/SCAVENGING ACRYLIC CEMENT Precision Medical Devices, Inc. KIH Class I 1984-02-09
K833907 CREIGHTON FIXATOR Patton Machine Co. JDW Class II 1984-02-09
K840100 PATELLA PROSTHESIS Techmedica, Inc. JWH Class II 1984-02-09
K840286 BROOKER EXTERNAL FIXATION FRAME Depuy, Inc. JDW Class II 1984-02-09
K833921 AGC TOTAL KNEE PROSTHESIS Biomet, Inc. JWH Class II 1984-01-31
K833991 BIPOLAR HIP DEVICE Zimmer KWY Class II 1984-01-30
K832991 HYPAL ADHESIVE TAPE Smith & Nephew, Inc. KQX Class I 1984-01-30
K834384 MODULAR EXTREMITY CASTING SUPPORT Buckman Co., Inc. LGG Class I 1984-01-30
K833970 MICRO-STRUCTURED HS2P HIP STEMS Osteonics Corp. LWJ Class II 1984-01-27
K833464 POROCOAT SCHATZKER ACETABULUM Depuy, Inc. LPH Class II 1984-01-27
K834411 TECHMEDICA-HEWSON SHOULDER CLEAT Techmedica, Inc. HTN Class II 1984-01-17
K833881 ACETABULAR SCREW RING Mecron Medical Products, Inc. JDI Class II 1984-01-13
K834229 BONE PLUGGING TOOL Standard Surgical HTW Class I 1984-01-10
K833403 BDH UNIPOLAR FEMORAL COMPONENT A2 Carbomedics, Inc. KWL Class II 1984-01-10
K834076 ARTHROSCOPIC LEG HOLDER 434-21 Custom Medical Products, Ltd. HRX Class II 1983-12-27
K833468 BDH UNIVERSAL HIP SYSTEM SURGEON Carbomedics, Inc. JDG Class II 1983-12-27
K833411 KNEE PROSTHESIS-PATELLA COMPONENT Johnson & Johnson Professionals, Inc. JWH Class II 1983-12-22
K833726 KLEIN WIRE TIGHTENER/BIONIC WIRE Bionic Instrument Corp. HXS Class I 1983-12-22
K833175 BIOMET BIPOLAR PROSTHESIS Biomet, Inc. KWY Class II 1983-12-22
K833912 GALANTE FIBER METAL TOTAL HIP Zimmer, Inc. JDI Class II 1983-12-22
K833865 ACE BROOKER BONE PLATING SYSTEM Buckman Co., Inc. HRS Class II 1983-12-12
K833727 CABOT ARTHROSCOPY SYSTEM Cabot Medical Corp. HRX Class II 1983-12-12
K833675 BRIGHAM TIBIAL CEMENT PRESSURIZER Howmedica Corp. KIH Class I 1983-12-12
K833200 TRICON M TOTAL KNEE SYSTEM Richards Medical Co., Inc. MBV Class II 1983-11-29
K833587 DISPOSABLE ARTHROSCOPY BLADE Dyonics, Inc. HRX Class II 1983-11-14
K833409 MONOSPHERICAL RESURFACING GLENOID PROS Howmedica Corp. KWT Class II 1983-11-07
K833410 MONOSPHERICAL GLENOID PROSTH. KEEL Howmedica Corp. KWS Class II 1983-11-07
K832328 INTRAMEDULLARY BONE PLUG Kirschner Medical Corp. JDS Class II 1983-10-20
K832884 FIXATION STAPLE DRIVER/EXTRACTOR Warsaw Orthopedic, Inc. JDR Class II 1983-10-20
K833114 OXFORD MARK 2 EXTERNAL FIXATOR Johnson & Johnson Professionals, Inc. JEC Class II 1983-10-20
K832686 MULTIPLE MANUAL SURGICAL INSTRUMENTS Hirata Sangyo Co. USA, Inc. HTO Class I 1983-10-14
K833084 MASTERHINGE Mark One Healthcare Products LGF Class I 1983-10-14
K831851 STRAIGHT STEM FEMORAL HEAD PROSTHESIS Proteck, Inc. KWL Class II 1983-10-06
K832341 ARTHROSCOPE-VARIOUS MODELS FIBEROPTIC Kamiya Tsusan Kaisha, Ltd. HRX Class II 1983-10-04
K832315 ARTHROSCOPY FLUID MGMT. SYSTEM 3M Health Care, Sarns HRX Class II 1983-10-04
K832958 FREEMAN ACETABULAR CUP Depuy, Inc. JDI Class II 1983-10-04
K832211 DOSIMETRIC RELEASE OF GAMMA RADIATION Kirschner Medical Corp. JDI Class II 1983-09-29
K830361 MMS ACETABULAR CUPS 3M Company JDI Class II 1983-09-29
K831884 SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL Richards Manufacturer Co. JDI Class II 1983-09-20
K831982 BRADFORD SPINAL FRACTURE FIXATION SYS Depuy, Inc. KWQ Class II 1983-09-20
K831420 HIP PROSTHESIS -VARIOUS The Oec Group KWL Class II 1983-09-20
K831441 POROCOAT FREEMAN/SAMUELSON TOTAL KNEE Depuy, Inc. MBV Class II 1983-09-01
K831373 P.C.A. HIP SYSTEM Howmedica Corp. JDI Class II 1983-08-26
K832277 ACUFLEX LEVY ACL DRILL GUIDE SYS Acufex Microsurgical, Inc. HRX Class II 1983-08-16
K831143 P.C.A. UNICOMPARTMENTAL KNEE PROSTHES Howmedica Corp. HRY Class II 1983-08-16
K832302 MARK I TOTAL KNEE SYS. ARTHROPLASTY Advanced Biosearch Assn. MBV Class II 1983-08-16
K831873 BONE SCREW W. L. Gore & Associates, Inc. HWC Class II 1983-08-12
K831986 METAL-BACKED ACE TABULAR CUP Kirschner Medical Corp. JDI Class II 1983-08-08
K831513 KENNEDY TIBIAL COMPONENT Biomet, Inc. HSX Class II 1983-07-28
K831898 SCOLIMETER Dr. Micheal A. Sabia KTZ Class I 1983-07-19
K830927 KNEE PROSTHESIS-TIBIAL COMPONENT Johnson & Johnson Professionals, Inc. JWH Class II 1983-07-19
K831218 ARTHROSCOPY INFUSION SYS..VALVE Acufex Microsurgical, Inc. HRX Class II 1983-07-18
K831040 LAMOREUX-OSI ELECTROGONIOMETER Orthopedic Systems, Inc. KQX Class I 1983-07-12
K830948 WEBER/STIIHMER FEMORAL HEAD PROSTHESIS Allo Pro Corp. JDI Class II 1983-07-12
K831314 INTERFERENCE MEDULLARY FIT -IMF-HIP Depuy, Inc. JDI Class II 1983-07-12
K831888 COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG Portable Travtion Device Co. HST Class I 1983-07-12
K831712 SURGICAL DRILL BITS Medical Specialists IN Packaging HTW Class I 1983-07-07
K831656 ARTHROSCOPY KNIVES/PROBES/BENDING TOOL Richards Manufacturer Co. HRX Class II 1983-06-30
K831550 FINGER BONIOMETER BK7506 Fred Sammons, Inc. KQW Class I 1983-06-24
K830314 MILWAUKEE AUSTIN MOORE TOTAL HIP Biomet, Inc. JDI Class II 1983-06-24
K831248 PATELLAR FAT PAD RETRACTOR Techmedica, Inc. HRX Class II 1983-06-24
K831002 TPG 1000 Physical Diagnostics, Inc. KQZ Class I 1983-06-24
K830726 MARK I & II TOTAL KNEE REPLACE. SYS Advanced Biosearch Assn. MBV Class II 1983-06-22
K830673 CRAFON ARTHROSCOPY LINES Gambro, Inc. HRX Class II 1983-06-08
K831576 ORTHOFIX Electro-Biology, Inc. JEC Class II 1983-06-08
K831072 JURGAN PIN BALL Jurgan Development & Mfg., Ltd. LYT Class II 1983-06-08
K831233 GLENOID RESURFACING COMPONENT-3M-10816 3M Company KWT Class II 1983-06-03
K831234 GLENOID RESURFACE COMPONENT PMN 3M 3M Company KWT Class II 1983-06-02
K830313 CFE TOTAL HIP FEMORAL COMPONENT Biomet, Inc. JDI Class II 1983-05-25
K831005 WIRE & STEINMAN PINS Kirschner Medical Corp. HTY Class II 1983-05-18
K830209 LUS ACETABULAR COMPONENT Biomet, Inc. JDI Class II 1983-05-16
K830857 HARRIS A.R. C. ACETABULAR CUP Howmedica Corp. JDI Class II 1983-05-09
K830750 CEMENTED 101 32 FEMORAL COMPONENT Intermedics Orthopedics JDI Class II 1983-05-02
K831076 COMPRESSION SYSTEM Kirschner Medical Corp. JDO Class II 1983-04-28
K831043 ANDREWS REMOTE CHUCK DRILL Orthopedic Systems, Inc. HXY Class I 1983-04-28
K830121 INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE Zimmer, Inc. JWH Class II 1983-04-26
K830004 POROCOAT DUAL-LOCK TOTAL HIP SYSTEM Depuy, Inc. JDI Class II 1983-04-19
K830662 NATURAL LOCK ACETABULAR COMPONENT Advanced Biosearch Assn. JDL Class III 1983-04-11
K823837 RMC TOTAL KNEE SYSTEM Richard'S Medical Equip., Inc. MBV Class II 1983-03-29
K830196 CORSTREN COMPRESSION TUBE & PLATE Zimmer, Inc. KTT Class II 1983-03-25
K830120 IMPROVED ARTHROSCOPE Markoptic HRX Class II 1983-03-17
K830499 ESA ELECTROSURGICAL ARTHROSCOPY GENERA Concept, Inc. HRX Class II 1983-03-17
K830307 AUFRANC-TURNER ATS TOTAL HIP SYSTEM Howmedica Corp. KWL Class II 1983-03-10
K823723 SPECTRON PROXIMAL FEMORAL PROSTHESIS Richard'S Medical Equip., Inc. JDI Class II 1983-03-09
K823726 SPECTRON CONVERSION ENDOPROSTHESIS CUP Richard'S Medical Equip., Inc. KWY Class II 1983-03-09

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