meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
42
Latest Decision
1987-06-03

Clearances · page 163 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K871772 KINEMATIC III POST CRUCIATE TOTAL CONDYLAR KNEE SY Howmedica Corp. JWH Class II 1987-06-03
K871248 KRONNER COLLES-FOREARM EXTERNAL FIXATION Kronner Medical KTT Class II 1987-06-03
K871769 OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION) Osteonics Corp. JWH Class II 1987-06-02
K870786 AXIAL COMPRESSION SCREW Straub Clinic and Hospital KTT Class II 1987-06-01
K870235 OMNIFIT II HIP PROSTHESES: CEMENT FIXATION Osteonics Corp. JDI Class II 1987-05-29
K870843 SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA Warsaw Orthopedic, Inc. HWT Class I 1987-05-27
K870842 SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP Warsaw Orthopedic, Inc. HTP Class I 1987-05-27
K871510 MODIFIED PROFILE HIP PMMA CEMENT SPACER Depuy, Inc. JDI Class II 1987-05-27
K870730 NOILES TOTAL KNEE PROSTHESIS Joint Medical Products Corp. JWH Class II 1987-05-26
K871247 KRONNER UNIVERSAL FRAME EXTERNAL FIXATION Kronner Medical KTT Class II 1987-05-22
K871249 KRONNER BI-PLANER TIBIA EXTERNAL FIXATION Kronner Medical KTT Class II 1987-05-22
K864375 TYPE 316L COTTER WIRE Winn Hirsch & Assoc. LRN Class II 1987-05-20
K871401 KIRSCHNER MODULAR HIP SYSTEM Kirschner Medical Corp. JDI Class II 1987-05-18
K870654 EFER ARTHROSCOPE Roseburg SA HRX Class II 1987-05-14
K870128 HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE) Richards Medical Co., Inc. JDI Class II 1987-05-13
K870867 KM-4(TM) METAL-BACKED ACETABULAR CUP Kirschner Medical Corp. JDL Class III 1987-05-08
K871608 RODRIGUEZ NAIL Richards Medical Co., Inc. HSB Class II 1987-05-08
K870082 BONE PLATE Terray Manufacturing, Inc. HRS Class II 1987-05-06
K870830 WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM Warsaw Orthopedic, Inc. KWP Class II 1987-05-04
K871323 ARTHROSCOPIC MENISCAL SUTURE SYSTEM Orthopedic Systems, Inc. HWT Class I 1987-05-01
K870699 STANDARD POROCOAT MODIFIED MEDIAL ASPECT AML HIP Depuy, Inc. JDI Class II 1987-05-01
K871299 SDI TOTAL HIP SYSTEM Orthomet, Inc. JDI Class II 1987-04-27
K870271 S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP Joint Medical Products Corp. KWZ Class II 1987-04-20
K865066 ARTHROFLATOR F.M. Wiest USA, Inc. HRX Class II 1987-04-20
K870702 ADG PATELLAR COMPONENT Buckman Co., Inc. JWH Class II 1987-04-17
K864489 SWANSON TITANIUM TRAPEZIUM IMPLANT Dow Corning Wright KYI Class II 1987-04-15
K864491 SWANSON TITANIUM CARPAL LUNATE IMPLANT Dow Corning Wright KWN Class II 1987-04-15
K864488 SWANSON TITANIUM CONDYLAR IMPLANT Dow Corning Wright KYI Class II 1987-04-15
K871296 T.E.D.(TM) TRACTION DEVICE The Kendal Co. KQZ Class I 1987-04-15
K864492 SWANSON TITANIUM GREAT TOE IMPLANT Dow Corning Wright KWD Class II 1987-04-15
K864490 SWANSON TITANIUM CARPAL SCAPHOID IMPLANT Dow Corning Wright KWO Class II 1987-04-15
K871118 MODIFIED TOWNLEY UNICONDYLAR KNEE Depuy, Inc. KYK Class II 1987-04-06
K870388 HOFFMANN LEG LENGTHENING PLATE SYSTEM Howmedica Corp. HRS Class II 1987-04-03
K870262 FENLIN II SHOULDER PROSTHESIS Zimmer, Inc. KWS Class II 1987-04-03
K870915 SIMPULSE ARTHROSCOPY IRRIGATION SYSTEM C.R. Bard, Inc. HRX Class II 1987-04-01
K870040 INTRAMEDULLARY NAIL The Deca Co. HSB Class II 1987-03-26
K871037 CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW Concept, Inc. HWC Class II 1987-03-25
K862632 INSALL/BURSTEIN(TM)* II TIBIAL WEDGES Zimmer, Inc. HSX Class II 1987-03-25
K864857 OPTI-FIX ACETABULAR COMPONENT Richards Medical Co., Inc. JDI Class II 1987-03-24
K870216 MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS Osteonics Corp. JDI Class II 1987-03-20
K864924 KIRSCHNER (R) SMALL FRAGMENT FIXATION SYSTEM Kirschner Medical Corp. HRS Class II 1987-03-20
K870234 P.T.H. METAL-BACKED ACETABULAR CUP Orthopaedic Device Corp. JDL Class III 1987-03-20
K870445 THREADED ACETABULAR COMPONENT Johnson & Johnson Professionals, Inc. JDI Class II 1987-03-20
K870961 RICHARDS EXTERNAL FIXATION SYSTEM Richards Medical Co., Inc. KTT Class II 1987-03-19
K870767 THE (CROM) TESTER Twin City Surgical, Inc. KQW Class I 1987-03-17
K870847 SCHULTZ PHALANGEAL COMPONENT DRIVER Warsaw Orthopedic, Inc. HWR Class I 1987-03-13
K864515 RING UPM TOTAL HIP REPLACEMENT Downs Surgical , Ltd. KWA Class III 1987-03-13
K870848 SCHULTZ METACARPAL COMPONENT DRIVER Warsaw Orthopedic, Inc. HWR Class I 1987-03-13
K870846 SCHULTZ MP COMPONENT PUNCH Warsaw Orthopedic, Inc. HWP Class I 1987-03-13
K870844 SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR Warsaw Orthopedic, Inc. HWB Class I 1987-03-13
K870845 WARSAW ORTHOPEDIC POINTED REAMER Warsaw Orthopedic, Inc. HTO Class I 1987-03-11
K870053 TORQUEDRIVER WRENCH Jerome Medical HXC Class I 1987-03-11
K870727 WARSAW ORTHOPEDIC I BONE PLATE Warsaw Orthopedic, Inc. KTW Class II 1987-03-09
K870668 DRIVER-BENDER-EXTRACTOR, BONE PIN Military Engineering, Inc. HXW Class I 1987-03-09
K870779 ACROMED WALLIE-HEINIG TROCHAR Buckman Co., Inc. HWJ Class I 1987-03-09
K864632 P.C.A. MODULAR KNEE SYSTEM Howmedica Corp. JWH Class II 1987-03-06
K864518 LACEY PRESS-FIT CONDYLAR TOTAL KNEE Dow Corning Wright JWH Class II 1987-03-04
K870083 FERRAY EXTRACTOR Terray Manufacturing, Inc. HWB Class I 1987-02-26
K870212 ARTHROSCOPIC SHOULDER HOLDER Dyonics, Inc. HST Class I 1987-02-20
K870404 COLORED CASTING TAPE (RED AND BLUE) Buckman Co., Inc. LGF Class I 1987-02-13
K861988 MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY Protek, Inc. JDI Class II 1987-02-11
K870217 FEMORAL CEMENT REMOVAL INSTRUMENTS Kenneth J. Hoek, M.D., Inc. HTW Class I 1987-02-06
K864671 ANATOMIC MODULAR KNEE (AMK) SYSTEM Depuy, Inc. JWH Class II 1987-02-06
K864627 WHITESIDE ORTHOLOC II METAL BACKED PATELLA Dow Corning Wright JWH Class II 1987-02-04
K870125 EXTREMITY ELEVATOR Orthopedic Systems, Inc. HST Class I 1987-02-04
K870141 URESIL T-SYSTEM BONE SCREWS Uresil Corp. HWC Class II 1987-02-03
K870102 TUPPER TROLLEY Orthopedic Systems, Inc. HST Class I 1987-02-03
K864085 BROOKER BIO-GROOVE FEMORAL COMPONENT Biomet, Inc. KWL Class II 1987-01-28
K870084 RD 140 SURGICAL BENDER Terray Manufacturing, Inc. HXW Class I 1987-01-28
K870100 PLASTER STAND Orthopedic Systems, Inc. LGG Class I 1987-01-28
K864070 WHITESIDE ORTHOLOC (TM) Dow Corning Wright HRY Class II 1987-01-27
K863184 PROFILE HIP ACETABULUM PROSTHESIS Depuy, Inc. JDI Class II 1987-01-15
K861979 AML II TITANIUM ACETABULUM PROSTHESIS Depuy, Inc. JDI Class II 1987-01-15
K864892 ELLISON ARTHROSCOPY CHEATER Buckman Co., Inc. HRX Class II 1986-12-30
K862837 OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM Osteonics Corp. HSX Class II 1986-12-22
K863668 OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM Osteonics Corp. JWH Class II 1986-12-19
K864403 MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM Howmedica Corp. LXT Class II 1986-12-18
K864633 VITALLIUM HEX-DRIVE BONE SCREW SYSTEM Howmedica Corp. HWC Class II 1986-12-18
K864765 MODEL 668, TRACTION SPLINT, ADULT Ferno-Washington, Inc. HST Class I 1986-12-17
K864092 OEC DESIGN ORTHOPEDIC CAST HEEL Military Engineering, Inc. LGF Class I 1986-12-16
K864626 CANCELLOUS BONE SCREW Dow Corning Wright HWC Class II 1986-12-15
K862017 ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT Dyonics, Inc. HRX Class II 1986-12-15
K864476 LEG HOLDER American Container Technology, Inc. HRX Class II 1986-12-15
K863667 MODIFIED SYNATOMIC KNEE PATELLA PROSTHESIS Depuy, Inc. JWH Class II 1986-12-12
K863805 MILLER/GALANTE TOTAL KNEE POR COATED PATELLAR DOME Zimmer, Inc. JWH Class II 1986-12-02
K864426 RAYLOR(TM) DEPTH GAUGE Cedar Surgical, Inc. HTJ Class I 1986-11-26
K864513 LP ARTHROSCOPIC THIGH HOLDING DEVICE Twin Falls Orthopedic Associates, P.A. HRX Class II 1986-11-25
K864422 RAYLOR(TM) MALLET Cedar Surgical, Inc. HWA Class I 1986-11-24
K864163 HALL DUNBAR DRILL GUIDE SYSTEM Hall Surgical, Division of Zimmer, Inc. HRX Class II 1986-11-20
K863986 XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES American Edwards Laboratories HRX Class II 1986-10-31
K862991 LIGAMENT WASHER Orthopedic Systems, Inc. HRX Class II 1986-10-29
K862990 CANCELLOUS SCREW Orthopedic Systems, Inc. HRX Class II 1986-10-29
K861433 UNIVERSAL ACETABULAR COMPONENT Biomet, Inc. JDI Class II 1986-10-27
K863590 UNIVERSAL CANNULA SYSTEM Aspen Laboratories, Inc. HRX Class II 1986-10-23
K863734 STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS Micro-Aire Surgical Instruments, Inc. HTY Class II 1986-10-20
K862234 EXACTECH TOTAL HIP SYSTEM Exactech, Inc. JDI Class II 1986-10-15
K862460 FEMORAL HEMI-HIP PROSTHESIS Orthopaedic Device Corp. KWY Class II 1986-10-06
K863605 ARTHROSCOPIC IRRIGATION PUMP American Edwards Laboratories HRX Class II 1986-10-03
K863597 AMERICAN EDWARDS 4.0 MM ARTHROSCOPE American Edwards Laboratories HRX Class II 1986-09-25
K863343 SUPERFIXATION(TM) Orthopaedic Device Corp. KTT Class II 1986-09-15

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