meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
27
Latest Decision
1991-01-18

Clearances · page 156 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K903877 MTS FEMORAL HIP SYSTEM 3M Company KWL Class II 1991-01-18
K903697 HAWAIIAN SUPRACONDYLAR PLATE Medpac HRS Class II 1991-01-15
K904028 DCW MODULAR PROXIMAL FEMORAL SYSTEM Dow Corning Wright LZO Class II 1991-01-14
K902365 MODULAR UNIPOLAR SYSTEM Howmedica Corp. KWL Class II 1991-01-11
K903976 CTH STABILO TOTAL HIP REPLACEMENT SYSTEM Kinamed, Inc. LZO Class II 1991-01-09
K904207 BIOPRO TRINITY ACETABULAR CUP Biopro, Inc. JDI Class II 1991-01-04
K905333 U.S. TYPE CRUCIATE SLOT BONE SCREW O'Tec Corp. HWC Class II 1991-01-04
K905357 CORTICAL BONE SCREW (EUROPEAN STYLE) O'Tec Corp. HWC Class II 1991-01-04
K905347 HAGIE PIN O'Tec Corp. JDW Class II 1991-01-04
K903938 C FIT CUP Orthopedic Systems, Inc. JDI Class II 1991-01-04
K905406 OSTEONICS HIP REVISION WEDGES Osteonics Corp. JDI Class II 1991-01-04
K905355 BROAD SELF-COMPRESSING PLATE O'Tec Corp. HRS Class II 1991-01-04
K905112 SNAP-PAK (TM) Mitek Surgical Products, Inc. JDR Class II 1991-01-04
K902167 CONTAIN(TM) LASER PLUME FILTER Arbor Technologies, Inc. JDY Class I 1991-01-04
K905158 OSTEONICS(R) 6011 HIP STEM SERIES Osteonics Corp. JDI Class II 1991-01-04
K905358 CANCELLOUS SCREW O'Tec Corp. HWC Class II 1991-01-04
K896851 PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC Lima Intl. Corp. JDI Class II 1991-01-01
K903946 COOL CAST(R) Hawthorne Products, Inc. LGF Class I 1990-12-31
K903376 ACROMED SACRAL SCREW Acromed Corp. KWP Class II 1990-12-27
K904553 BONE STAPLE(S) Synthes (Usa) JDR Class II 1990-12-21
K904383 ACUFIT TOTAL HIP Acu Med, Inc. KWY Class II 1990-12-20
K904465 FLEXIBLE ARTHROSCOPE Intramed Laboratories, Inc. HRX Class II 1990-12-20
K896047 THE OMNIFIT EPF HIP JOINT FEMORAL STEM Osteonics Corp. MEH Class II 1990-12-20
K905342 LAG SCREW O'Tec Corp. KTT Class II 1990-12-11
K905349 AUSTIN MOORE TYPE HIP PROTHESIS O'Tec Corp. KWL Class II 1990-12-11
K905352 BLADE PLATE O'Tec Corp. KTT Class II 1990-12-11
K905346 JEWETT HIP NAIL O'Tec Corp. KTT Class II 1990-12-11
K905345 K-WIRE O'Tec Corp. HTY Class II 1990-12-11
K905336 STEINMAN PIN, THREADED O'Tec Corp. JDW Class II 1990-12-11
K905338 SIDE PLATE O'Tec Corp. KTT Class II 1990-12-11
K905364 ROUND STAPLE O'Tec Corp. JDR Class II 1990-12-11
K905348 HANSEN-STREET TYPE INTRAMEDULLARY NAIL O'Tec Corp. KTW Class II 1990-12-11
K905337 STEINMAN PIN O'Tec Corp. HTY Class II 1990-12-11
K905341 RUSH PIN O'Tec Corp. HTY Class II 1990-12-11
K905344 KNOWLES PIN O'Tec Corp. JDW Class II 1990-12-11
K905362 BARBED SQUARE STAPLE O'Tec Corp. JDR Class II 1990-12-11
K905334 THOMPSON TYPE HIP PROSTHESIS O'Tec Corp. KWL Class II 1990-12-11
K905363 FIXATION STAPLE O'Tec Corp. JDR Class II 1990-12-11
K901005 TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS) Danek Medical, Inc. KWP Class II 1990-12-10
K902775 KNIGHT SACRAL SCREW Danek Medical, Inc. KWP Class II 1990-12-10
K904919 PROXIMAL FEMUR REPLACEMENT STEM Depuy, Inc. JDI Class II 1990-12-05
K904284 ARTHROSCOPIC SURGICAL BLADE Smith & Nephew Dyonics, Inc. HRX Class II 1990-12-05
K904844 PRECISION HIP STEM WITH ADDITIONAL STEM SIZES Howmedica Corp. JDI Class II 1990-12-05
K903461 TSRH OFFSET AND SIDE-LOADING HOOKS Danek Medical, Inc. KWP Class II 1990-12-05
K904156 ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS Origin Medsystems, Inc. LZV Class II 1990-11-27
K903957 VSP HIP STEM Turnkey Intergration USA, Inc. JDI Class II 1990-11-26
K904180 PROSTHETIC CEMENT REMOVER Origin Medsystems, Inc. LZV Class II 1990-11-20
K903886 OSTEONICS SR GLENOID COMPONENTS Osteonics Reconstructive Products Div. KWS Class II 1990-11-20
K903635 PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. JDI Class II 1990-11-09
K901587 TSRH SACRAL L-CONNECTOR Danek Medical, Inc. KWP Class II 1990-11-05
K902397 MODULOCK POSTERIOR SPINAL FIXATION Zimmer, Inc. KWP Class II 1990-11-05
K904479 SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015 Percutaneous Technologies HRX Class II 1990-11-02
K903636 OSTEONICS DRM ACETABULAR COMPONENT Osteonics Corp. JDI Class II 1990-10-30
K902778 SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER Surgical Dynamics, Inc. HRX Class II 1990-10-30
K902056 LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER Hollister, Inc. JDY Class I 1990-10-30
K904720 POWERCUT SURGICAL SYSTEM, BLADES, AND ACCESSORIES Baxter Healthcare Corp HRX Class II 1990-10-26
K903116 RM ISOELASTIC BEVELLED ACETABULAR CUP Robert Mathys Co. JDI Class II 1990-10-23
K900612 SHEPPERD TREPHINE SET (GS-501-30-V) Downs Surgical , Ltd. HRX Class II 1990-10-22
K900615 SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE Downs Surgical , Ltd. HRX Class II 1990-10-22
K903362 OSTEOLOCK(TM) ACETABULAR CUP Howmedica Corp. JDI Class II 1990-10-22
K904205 AMK MODULAR TIBIAL WEDGE SYSTEM Depuy, Inc. JWH Class II 1990-10-22
K900610 SHEPPERD CANNULA STILLETTE & OBDURATOR SET Downs Surgical , Ltd. HRX Class II 1990-10-22
K900616 SHEPPERD CUTTING FORCEPS Downs Surgical , Ltd. HRX Class II 1990-10-22
K900614 SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V) Downs Surgical , Ltd. HRX Class II 1990-10-22
K901581 GSB ELBOW Allo Pro Corp. JDC Class II 1990-10-22
K900613 SHEPPERD SHELTER TUBE COMPLETE & DRILL Downs Surgical , Ltd. HRX Class II 1990-10-22
K900611 SHEPPERD DILATATION TUBE SET (GS-501-20-H) Downs Surgical , Ltd. HRX Class II 1990-10-22
K900608 SHEPPERD LUMBAR DISCECTOMY SYSTEM Downs Surgical , Ltd. HRX Class II 1990-10-22
K900609 SHEPPERD STRAIGHT AND CURVED NEEDLES Downs Surgical , Ltd. HRX Class II 1990-10-22
K904340 FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM Neoligaments, Ltd. JDR Class II 1990-10-19
K903312 CYGNASCOPE Cygnus Instruments, Inc. HRX Class II 1990-10-19
K904170 PCA (R) TIBIAL BONE WEDGES Howmedica Corp. JWH Class II 1990-10-17
K904300 INSET PATELLAR COMPONENT Johnson & Johnson Orthopaedics, Inc. JWH Class II 1990-10-17
K904351 FOCUS COBALT CHROMIUM TOTAL HIP Depuy, Inc. JDI Class II 1990-10-17
K903811 ACE CANNULATED CORTICAL BONE SCREW Ace Medical Co. HWC Class II 1990-10-16
K903810 ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW Ace Medical Co. HWC Class II 1990-10-16
K903286 CONTINUUM KNEE SYSTEM (CKS)-MODIFICATION Techmedica, Inc. HSX Class II 1990-10-12
K903620 MODIFIED ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM Smith & Nephew Dyonics, Inc. HRX Class II 1990-10-12
K904119 PROFILE COLLARED HIP PROSTHESIS Depuy, Inc. KWL Class II 1990-10-11
K903234 F-19 TOTAL HIP PROSTHESIS Med-Tek Corp. JDI Class II 1990-10-10
K901144 LEVTECH BONE SCREW Levtech, Inc. HWC Class II 1990-10-10
K904021 PNEUMOTHORAX KIT, MODIFICATION Arrow Intl., Inc. JDC Class II 1990-10-09
K901234 KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE Kirschner Medical Corp. KTT Class II 1990-10-04
K900051 MOORE TYPE ENDO PROSTHESIS Lima Intl. Corp. KWY Class II 1990-10-03
K902961 DIMENSION-II TOTAL HIP SYSTEM Kirschner Medical Corp. JDI Class II 1990-10-03
K903084 MODULAR CATHCART FRACTURE SYSTEM Depuy, Inc. LZY Class II 1990-10-03
K901290 ELECTRO-GONIOMETER DIAGNOSTIC DEVICE Chattanooga Group, Inc. LBB Class II 1990-10-01
K901289 RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS Mumtaz I. Malik LXH Class I 1990-09-28
K901511 CHISEL, BONE, SURGICAL Mumtaz I. Malik LXH Class I 1990-09-28
K901521 OSTEOTOMES OF VARIOUS TYPES Mumtaz I. Malik LXH Class I 1990-09-28
K901420 VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8 Mumtaz I. Malik LXH Class I 1990-09-28
K902855 NEW JERSEY TOTAL SHOULDER GLENOID COMPONENT Depuy, Inc. KWS Class II 1990-09-20
K901085 DORR KNEE SYSTEM Intermedics Orthopedics JWH Class II 1990-09-19
K902676 MICROGUARD, ORTHOPEDIC PIN PROTECTORS Micro-Aire Surgical Instruments, Inc. LYT Class II 1990-09-14
K900262 ACSYS SELFTAP ACETABULAR CUP PROSTHESIS 3M Company LWJ Class II 1990-09-14
K902053 K-CAP-I ORTHOPEDIC FIXATION WIRE CAP Westcon Orthopedics, Inc. LYT Class II 1990-09-14
K900261 ACSYS PREFIX ACETABULAR CUP PROSTHESIS 3M Company JDI Class II 1990-09-14
K900435 ACSYS SHEARER ACETABULAR CUP PROSTHESIS 3M Company LWJ Class II 1990-09-14
K894959 CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO Alphatec Mfg., Inc. JEC Class II 1990-09-14
K903884 KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD Kinamed, Inc. KWL Class II 1990-09-13

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