meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
48
Latest Decision
1981-10-20

Clearances · page 169 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K812801 HIP STEM SYSTEM TITANIUM ALLOY Osteonics Corp. JDI Class II 1981-10-20
K802342 PROXIMAL INTERPHALANGEAL JOINT IMPLANT Sutter Biomedical, Inc. JDI Class II 1981-10-14
K812672 SELF-CENTERING HIP Depuy, Inc. KWY Class II 1981-10-08
K812669 SEATTLE II TOTAL HIP SYSTEM Hexcel Medical JDG Class II 1981-10-02
K812687 BRIGHAM II TOTAL HIP SYSTEM Hexcel Medical JDG Class II 1981-10-02
K812012 TOWNLEY UNICONDYLAR KNEE Depuy, Inc. HRY Class II 1981-09-24
K812343 PINCH METER Fred Sammons, Inc. HRW Class I 1981-09-11
K812053 SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) Dow Corning Corp. Healthcare Industries Materials KXE Class II 1981-08-18
K812182 MIAMI, PROTRUSIO RING Zimmer, Inc. JDI Class II 1981-08-18
K811416 MOORE HIP PROSTHESIS, PMMA COATED Zimmer, Inc. KWL Class II 1981-08-12
K811105 SEMI-CONSTRAINT KEE JOINT HINGE PROSTH Allo Pro Corp. KRO Class II 1981-07-27
K811738 COLLARLESS TAPERED STEM HIP PROSTH. DEV Biomet, Inc. KWL Class II 1981-07-20
K811861 ARTHROSCOPIC LEG HOLDER Stryker Corp. HRX Class II 1981-07-16
K811679 SILASTIC TENDON PASSER H.P. Dow Corning Corp. Healthcare Industries Materials HWQ Class I 1981-07-10
K811630 KINEMATIC ROTATING HINGE TOTAL KNEE PR. Howmedica Corp. LGE Class II 1981-07-01
K811675 SURGICAL INSTRUMENTS FOR USE W/ZIMMER Zimmer, Inc. HRX Class II 1981-06-25
K811596 ZIMMER ARTHROSCOPY SYSTEM Zimmer, Inc. HRX Class II 1981-06-25
K811293 EFTEKHAR CENTRALIZING PLUG Zimmer, Inc. JDI Class II 1981-06-24
K811244 CRYOPHTHALMIC UNIT Keeler Instruments, Inc. HRS Class II 1981-06-23
K811500 COLBALT ALLOY ORTHOPAEDIC WIRE Osteonics Corp. JDR Class II 1981-06-18
K811451 RADIAL HEAD PROSTHESIS Cintor Orthopaedic Div. JDB Class II 1981-06-09
K811312 MYO-METRIC II Mycron Medical, Inc. LBB Class II 1981-06-09
K811317 HOWMEDICA FEMORAL PRESSURING SEAL Howmedica Corp. KIH Class I 1981-05-29
K811017 HUCKSTEP INTRAMEDULLARY NAIL Downs Surgical , Ltd. KTT Class II 1981-05-27
K811205 MOLDED POLYSULFONE TRIAL PROSTHESIS Shannon Group HWT Class I 1981-05-21
K811151 COLLARLESS TOTAL HIP FEMORAL COMP. SYS Howmedica Corp. JDI Class II 1981-05-15
K810847 PRITCHARD SURFACE REPLACEMENT ELBOW Depuy, Inc. JDB Class II 1981-05-01
K811002 ENDER PINS Richard'S Medical Equip., Inc. HSB Class II 1981-04-29
K811081 MEDULLARY CANAL SCRAPERS The Anspach Effort, Inc. HTO Class I 1981-04-29
K810956 MARCOVE HUMERAL ROD Hexcel Medical HSB Class II 1981-04-17
K810957 MARCOVE INTRAMEDULLARY ROD Hexcel Medical HSB Class II 1981-04-17
K810640 POLARISED LIGHT GRONIOMETER Cairco , Ltd. KQX Class I 1981-04-17
K810328 BIO CONDYLAR TM KNEE Depuy, Inc. JWH Class II 1981-04-08
K810329 DEPUY SEGMENTALSPINAL SYSTEM Depuy, Inc. KWP Class II 1981-04-08
K810060 P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH Howmedica Corp. HRY Class II 1981-04-07
K810540 KNEE PROSTHESIS Cintor Orthopaedic Div. HRY Class II 1981-04-07
K810520 INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL Zimmer, Inc. KRO Class II 1981-03-26
K810616 MILLER MULTI-RADIUS TOTAL KNEE Zimmer, Inc. HRY Class II 1981-03-20
K810542 CEMENT FUME EVACUATOR TANK & FILTER Walgen Medical Innoventions JDY Class I 1981-03-13
K810535 MOURADIAN MODIFIED ZICKEL HUMERAL ROD Howmedica Corp. HSB Class II 1981-03-13
K810497 BONE FIXACTION SCREW Serrano Intl. HWC Class II 1981-03-11
K810326 POROCOAT TM TOWNLEY ANATOMIC KNEE Depuy, Inc. JWH Class II 1981-03-11
K810230 CONDYLAR KNEE W/METAL ENCAPSULATED TIB Hexcel Medical HRY Class II 1981-03-06
K810258 PROXIMAL FERMORAL HIP REPLACEMENT Biomet, Inc. JDO Class II 1981-03-05
K810441 UNIVERSAL GONIMETER Fred Sammons, Inc. KQW Class I 1981-02-27
K810294 LINE CADDY Instranetics, Inc. HXB Class I 1981-02-26
K802348 TRIAXIAL Johnson & Johnson Professionals, Inc. JDB Class II 1981-02-23
K803167 BRIGHAM TOTAL ANKLE PROSTHESIS Howmedica Corp. HSN Class II 1981-02-19
K803106 AGINSKY NAIL Cintor Orthopaedic Div. HSB Class II 1981-02-12
K810224 ARMSTRONG SPINAL APPLIANCE Howmedica Corp. KWP Class II 1981-02-10
K803126 EXETER TOTAL HIP SYSTEM Howmedica Corp. JDI Class II 1981-02-10
K803127 HOWMEDICA KNEE BRUSH Howmedica Corp. LXH Class I 1981-02-10
K810267 FEMORAL CANAL BRUSH Richard'S Medical Equip., Inc. LXH Class I 1981-02-09
K810205 MECRON CANCELLOUS CANNULATED BONE SCREWS Serrano Intl. HWC Class II 1981-02-09
K803196 FLEXIBLE PIN S SHAPED INTRAMED. SYSTEM Howmedica Corp. HSB Class II 1981-02-09
K803235 GEO-TIBIAL RETAINER ROTATIONAL Zimmer, Inc. HSX Class II 1981-02-04
K810120 REINFORCED HIP CUP Biomet, Inc. JDI Class II 1981-02-04
K810116 ISOROBIC SKINFOLD CALIPER Fitness Motivation Institute of America KTZ Class I 1981-02-04
K810110 COBBLER'S CHIP SPLINTS Secol Co. LGF Class I 1981-01-26
K810062 BI-CENTRIC BI-POLAR ENDOPROSTHESIS Howmedica Corp. KWY Class II 1981-01-26
K803191 PROSTHESIS, HIP FEMORAL COMPONENT METAL Osteonics Corp. KWL Class II 1981-01-23
K803192 HCL ACETABULAR COMPONENTS Osteonics Corp. KWZ Class II 1981-01-23
K810061 CURVED SHERMAN BONE PLATE Howmedica Corp. HRS Class II 1981-01-23
K803176 INTEROOM(POWERED OPHTHALMIC TABLE) Jocevest Interoom, Inc. HRS Class II 1981-01-09
K803166 DOUBLE BALL JOINT Howmedica Corp. JEC Class II 1981-01-09
K803141 CONPHAR CAST HEELS Conphar, Inc. LGF Class I 1981-01-09
K802921 ICLH TIBIAL PLATEAU Depuy, Inc. MBV Class II 1981-01-08
K803074 FERNORAL HIP PROSTHESIS Cintor Orthopaedic Div. JDI Class II 1981-01-08
K801970 UCLA SHOULDER Howmedica Corp. KWS Class II 1980-12-31
K803165 ACETABULAR CEMENT COMPRESSOR Zimmer, Inc. HXO Class I 1980-12-31
K802922 POROUS COATED ANATOMICAL-TOTAL KNEE Howmedica Corp. JWH Class II 1980-12-17
K802951 I.M PROBES Hogan & Hartson HXB Class I 1980-12-17
K802462 SYNTHES SPINAL IMPLANT SYSTEM Synthes (Usa) KWP Class II 1980-12-16
K802627 ORTRON 90* HIP PROSTHESIS Cintor Orthopaedic Div. JDI Class II 1980-12-16
K803021 UPPER EXTREMITY TRACTION DEVICE Orthopedic Systems, Inc. HST Class I 1980-12-12
K802869 BACKTRAC 90-90 TRACTION Backtrac KQZ Class I 1980-12-11
K802872 AUFRANC-TURNER ATS TOTAL HIP SYSTEM Howmedica Corp. JDI Class II 1980-12-11
K802814 ORTHOFIX AXIALEXTERNAL FIXATION SYS. Cintor Orthopaedic Div. JEC Class II 1980-12-10
K802124 GRISTINA GLENOID PROSTHESIS Howmedica Corp. KWT Class II 1980-12-01
K802776 HOFFMAN LEG LENGTHENING DEVICE Howmedica Corp. JEC Class II 1980-11-19
K802723 EXTENDED BALLJOINT GRIP Howmedica Corp. JEC Class II 1980-11-19
K802722 EXTERNAL FIXATION SYSTEM Howmedica Corp. JEC Class II 1980-11-19
K802598 CARBIDE CUTTING INSTRUMENT/INTRAARTICU The Anspach Effort, Inc. HTT Class I 1980-11-19
K802460 HELFET ELBOW PROSTHESIS Depuy, Inc. JDB Class II 1980-11-19
K802694 JACOB CHUCK Richard Wolf Medical Instruments Corp. LXH Class I 1980-11-12
K802479 SURGICAL KNIVES & PROBES Eder Instrument Co, Inc. HXB Class I 1980-10-31
K802446 RANAWAT ESF TOTAL CONDYLAR KNEE Howmedica Corp. HRY Class II 1980-10-31
K801574 DEPALMA ELBOW Zimmer, Inc. JDB Class II 1980-10-31
K802555 COTTRELL 90/90 BACKTRAC Lossing Orthopedic, Inc. HST Class I 1980-10-31
K802032 MINI MICK APPLICATOR Mick Radio-Nuclear Instruments, Inc. JWJ Class II 1980-10-23
K802222 ANTERIOR KYPHOSIS DISTRACTION DEVICE Zimmer, Inc. KWQ Class II 1980-10-10
K801603 POLYETHYLENE FILLED BONE PLATE Zimmer, Inc. HRS Class II 1980-10-03
K802072 PROT-A-TRAC Robert I. Branick, M.D. HST Class I 1980-09-26
K801952 SPINE ALIGN B.H. Richardson, D.C. KYI Class II 1980-09-16
K802123 MONOSPHERICAL SHOULDER PROSTHESIS Howmedica Corp. HSD Class II 1980-09-16
K801594 ACE FISCHER EXTERNAL FIXATION DEVICE Ace Orthopedic Manufacturing Co. HXK Class I 1980-09-09
K800602 TALEISNIK TOTAL WRIST PROSTHESIS Dow Corning Wright KWM Class II 1980-08-27
K801719 BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG Fred Sammons, Inc. HRW Class I 1980-08-04
K801718 BK-7513 STAINLESS STEEL GONIOMETER Fred Sammons, Inc. KQW Class I 1980-08-04
K801717 BK-7511 BRASS GONIOMETER Fred Sammons, Inc. KQW Class I 1980-08-04

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