Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 29
- Latest Decision
- 1990-09-13
Clearances · page 157 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K903885 | KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD | Kinamed, Inc. | KWL | Class II | 1990-09-13 |
| K902621 | SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT | Lima Intl. Corp. | JDI | Class II | 1990-09-11 |
| K903676 | STERNOTOMY CABLE, SONGER CABLE SYSTEM | Danek Medical, Inc. | JDQ | Class II | 1990-09-10 |
| K901687 | F-24 FEMORAL HIP PROSTHESIS | Med-Tek Corp. | LWJ | Class II | 1990-09-07 |
| K903105 | OLIVE K-WIRES | Danek Medical, Inc. | JEC | Class II | 1990-09-06 |
| K901451 | F-20 CEMENTED METAL-BACKED ACETABULAR CUP | Med-Tek Corp. | JDI | Class II | 1990-08-31 |
| K902436 | HG MULTILOCK HIP PROSTHESIS W/TINIDIUM SURFACE | Zimmer, Inc. | JDI | Class II | 1990-08-29 |
| K902396 | MODIFIED DEPUY ACETABULAR CUP SYSTEM | Depuy, Inc. | JDI | Class II | 1990-08-24 |
| K902395 | MODIFIED AML + ACETABULAR CUP SYSTEM | Depuy, Inc. | JDI | Class II | 1990-08-24 |
| K902111 | MODIFIED FREEMAN REVISION ACETABULAR CUP | Turnkey Intergration USA, Inc. | KWA | Class III | 1990-08-22 |
| K902110 | MODIFIED FREEMAN ACETABULAR CUP | Turnkey Intergration USA, Inc. | KWA | Class III | 1990-08-22 |
| K902335 | NATURAL-KNEE SYSTEM SYSTEM W/COCR/CSTI(TM) | Intermedics Orthopedics | JWH | Class II | 1990-08-22 |
| K901814 | MCGRATH ORTHOPAEDIC BONE SCREWS | Mcgrath Surgical , Ltd. | HWC | Class II | 1990-08-21 |
| K901590 | DANEK SACRAL HOOK | Danek Medical, Inc. | KWP | Class II | 1990-08-21 |
| K901456 | ORTHOSORB(R) ABSORBABLE PIN | Johnson & Johnson International | OVZ | Class II | 1990-08-15 |
| K901626 | H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED | Med-Tek Corp. | KWA | Class III | 1990-08-14 |
| K895243 | BARNES FEMORAL LENGTHENING DEVICE | Piedmont Sports Medicine & Orthopaedic Clinic | HRS | Class II | 1990-08-10 |
| K902819 | LAMINECTOMY ROGEUR | Ruggles Corp. | LXH | Class I | 1990-08-09 |
| K903022 | FIXATION STAPLE | Onyx Medical Corp. | JDR | Class II | 1990-08-09 |
| K902712 | OSTEONICS PS HEAD AND NECK HIP STEM SERIES | Osteonics Corp. | LZO | Class II | 1990-08-09 |
| K903254 | U.S. TYPE CRUCIATE SLOT BONE SCREW | Onyx Medical Corp. | HWC | Class II | 1990-08-09 |
| K902727 | LSF CEMENTED FEMORAL HIP | Implant Technology, Inc. | JDI | Class II | 1990-08-09 |
| K895978 | CHIBA SPINAL SYSTEM | Danek Medical, Inc. | KWP | Class II | 1990-08-09 |
| K903253 | CANCELLOUS SCREW | Onyx Medical Corp. | HWC | Class II | 1990-08-09 |
| K903255 | CORTICAL BONE SCREW (EUROPEAN STYLE) | Onyx Medical Corp. | HWC | Class II | 1990-08-09 |
| K902279 | KM-5 METAL BACKED ACETABULAR CUP | Kirschner Medical Corp. | JDI | Class II | 1990-08-09 |
| K903252 | BROAD SELF-COMPRESSING PLATE | Onyx Medical Corp. | HRS | Class II | 1990-08-09 |
| K902246 | AMK UNIVERSAL FEMORAL COMPONENT | Depuy, Inc. | JWH | Class II | 1990-08-09 |
| K903258 | HAGIE PIN | Onyx Medical Corp. | HWC | Class II | 1990-08-09 |
| K903259 | KNOWLES PIN | Onyx Medical Corp. | HWC | Class II | 1990-08-09 |
| K901594 | H.N. TOTAL HIP PROSTHESIS | Med-Tek Corp. | LWJ | Class II | 1990-08-03 |
| K903265 | STEINMAN PIN | Onyx Medical Corp. | HTY | Class II | 1990-07-30 |
| K903243 | MULLER-TYPE FEMORAL COMPONENT | Onyx Medical Corp. | JDI | Class II | 1990-07-30 |
| K903242 | ACETABULAR CUP | Onyx Medical Corp. | JDI | Class II | 1990-07-30 |
| K903240 | THOMPSON TYPE HIS PROSTHESIS | Onyx Medical Corp. | KWL | Class II | 1990-07-30 |
| K903271 | ROUND STAPLE | Onyx Medical Corp. | JDR | Class II | 1990-07-30 |
| K903251 | JEWETT HIP NAIL | Onyx Medical Corp. | KTT | Class II | 1990-07-30 |
| K903244 | LAG SCREW | Onyx Medical Corp. | HWC | Class II | 1990-07-30 |
| K903270 | T-HANDLE HEX WRENCH | Onyx Medical Corp. | LXH | Class I | 1990-07-30 |
| K903264 | K-WIRE | Onyx Medical Corp. | HTY | Class II | 1990-07-30 |
| K903248 | COMBINATION REAMER | Onyx Medical Corp. | HTO | Class I | 1990-07-30 |
| K903247 | ADJUSTABLE ANGLE GUIDE | Onyx Medical Corp. | LXH | Class I | 1990-07-30 |
| K903250 | BLADE PLATE | Onyx Medical Corp. | KTT | Class II | 1990-07-30 |
| K903261 | RUSH PIN | Onyx Medical Corp. | JDW | Class II | 1990-07-30 |
| K903241 | AUSTIN MOORE TYPE HIP PROSTHESIS | Onyx Medical Corp. | KWL | Class II | 1990-07-30 |
| K903256 | HANSEN-STREET TYPE INTRAMEDULLARY NAIL | Onyx Medical Corp. | HSB | Class II | 1990-07-30 |
| K903273 | BARBED SQUARE STAPLE | Onyx Medical Corp. | JDR | Class II | 1990-07-30 |
| K903257 | DRIVER/EXTRACTOR | Onyx Medical Corp. | LXH | Class I | 1990-07-30 |
| K903266 | STEINMAN PIN, THREAD | Onyx Medical Corp. | JDW | Class II | 1990-07-30 |
| K903246 | SIDE PLATE | Onyx Medical Corp. | KTT | Class II | 1990-07-30 |
| K902751 | MITEK ANCHOR II | Mitek Surgical Products, Inc. | JDR | Class II | 1990-07-24 |
| K896471 | TENSTAPLE ORTHOPEDIC STAPLING SYSTEM | Tenstaple, Inc. | JDR | Class II | 1990-07-24 |
| K894228 | KRONNER SPHERICAL CUTTERS | Kronner Medical | HWT | Class I | 1990-07-23 |
| K901406 | ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED | Depuy, Inc. | JWH | Class II | 1990-07-23 |
| K902264 | TRUE/FLEX HUMERUS, ULNA AND RADIUS INTRAMEDULLARY | Applied Osteo Systems, Inc. | HSB | Class II | 1990-07-12 |
| K902567 | STAPLE, SERRATED, FIXATION W/SPIKES, VARIOUS SIZES | A. Henniss | JDR | Class II | 1990-07-10 |
| K902538 | WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION | Dow Corning Wright | HRY | Class II | 1990-07-06 |
| K895145 | SECOND GENERATION KNEE SYSTEM, FEMORAL, PATELLAR | Orthomet, Inc. | JWH | Class II | 1990-07-06 |
| K901744 | DOBBHOFF(R) RETRIEVAL FORCEPS | Biosearch Medical Products, Inc. | KQW | Class I | 1990-07-03 |
| K901936 | PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP | Orthomet, Inc. | JWH | Class II | 1990-07-03 |
| K902137 | P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENT | Johnson & Johnson Orthopaedics, Inc. | JDI | Class II | 1990-06-26 |
| K901992 | WHITESIDE ORTHOLOC MODULAR POST. STAB. KNEE SYSTEM | Dow Corning Wright | JWH | Class II | 1990-06-26 |
| K896106 | ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS | Richards Medical Co., Inc. | KWP | Class II | 1990-06-25 |
| K901765 | POSTEROMEDIAL GUIDE | Smith & Nephew Dyonics, Inc. | HRX | Class II | 1990-06-25 |
| K897141 | SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO | Stuart | JDN | Class II | 1990-06-21 |
| K901984 | ACE WIRE TENSION CLAMP | Buckman Co., Inc. | JEC | Class II | 1990-06-21 |
| K901616 | CANNULATED INTERFERENCE SCREW SYSTEM | Smith & Nephew Dyonics, Inc. | HWC | Class II | 1990-06-20 |
| K901735 | ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444 | Micro-Aire Surgical Instruments, Inc. | HRX | Class II | 1990-06-20 |
| K902168 | ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS) | Micro-Aire Surgical Instruments, Inc. | HRX | Class II | 1990-06-20 |
| K901457 | CONTINUUM KNEE SYSTEM (CKS) | Techmedica, Inc. | JWH | Class II | 1990-06-20 |
| K896254 | DANEK PRECISION ROD SET | Danek Medical, Inc. | KWP | Class II | 1990-06-14 |
| K896634 | CARAGLAS XTRA SYNTHETIC CASTING TAPE | Buckman Co., Inc. | LGF | Class I | 1990-06-14 |
| K901166 | DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER | Dalton Technology, Inc. | HXX | Class I | 1990-06-13 |
| K901480 | F-20 TOTAL HIP PROSTHESIS | Med-Tek Corp. | JDI | Class II | 1990-06-12 |
| K900619 | CAAS UNICOMPARMENTAL KNEE SYSTEM | Techmedica, Inc. | HSX | Class II | 1990-06-11 |
| K902074 | KINAMED CEMENTED CTH STEM | Kinamed, Inc. | LZO | Class II | 1990-06-08 |
| K901434 | PAPILLOTOME | Telemed Systems, Inc. | KWS | Class II | 1990-06-08 |
| K902073 | KINAMED CEMENTED ATH-LONG STEM | Kinamed, Inc. | LZO | Class II | 1990-06-08 |
| K896648 | CONCEPT UNICOMPARTMENTAL KNEE SYSTEM | Concept, Inc. | HSX | Class II | 1990-06-05 |
| K901273 | L.M.S. SELF-DETACHABLE BROACH WITH STOP | Med-Tek Corp. | HTY | Class II | 1990-06-05 |
| K896850 | LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE | Lima Intl. Corp. | LZO | Class II | 1990-06-05 |
| K901617 | ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR) | Smith & Nephew, Inc. | HRX | Class II | 1990-05-29 |
| K901328 | DOMED AND FINNED ACETABULAR COMPONENT | Orthomet, Inc. | JDI | Class II | 1990-05-22 |
| K901338 | KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM | Kirschner Medical Corp. | JWH | Class II | 1990-05-22 |
| K901460 | LSF(TM) TOTAL HIP SYSTEM | Implant Technology, Inc. | JDI | Class II | 1990-05-22 |
| K901364 | HGP II TOTAL HIP FEMERAL STEM | Zimmer, Inc. | JDI | Class II | 1990-05-18 |
| K900628 | MODULAR HIP SYSTEM | Richards Medical Co., Inc. | LZO | Class II | 1990-05-09 |
| K895117 | HTO COMPRESSING STAPLE | Howmedica Corp. | JDR | Class II | 1990-05-09 |
| K901087 | MODIFIED PROFILE II ACETABULAR CUP PROSTHESIS | Depuy, Inc. | JDI | Class II | 1990-05-07 |
| K892503 | NUFFIELD TOTAL KNEE | Orthopedic Systems, Inc. | JWH | Class II | 1990-05-04 |
| K900832 | MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA. | Depuy, Inc. | JDI | Class II | 1990-05-04 |
| K900812 | MEDICAM ARTHROSCOPE SYSTEMS | Kirschner Medical Corp. | HRX | Class II | 1990-05-03 |
| K901297 | EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP | Exactech, Inc. | JDI | Class II | 1990-05-02 |
| K896853 | PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA | Howmedica Corp. | KWL | Class II | 1990-05-02 |
| K900638 | P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT | Johnson & Johnson International | KWL | Class II | 1990-04-30 |
| K894098 | SYNTHES EXTERNAL FIXATION BONE CLIP | Synthes (Usa) | JEC | Class II | 1990-04-30 |
| K894184 | BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM | Biedermann Motech GmbH | JDN | Class II | 1990-04-25 |
| K901677 | CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER | Buckman Co., Inc. | LGH | Class I | 1990-04-23 |
| K901272 | ORION BLADE PLATE FOR TIBIAL OSTEOTOMY | Med-Tek Corp. | KTT | Class II | 1990-04-23 |
| K901525 | K-CAPE ORTHOPEDIC WIRES AND PINS | Westcon Orthopedics, Inc. | KTT | Class II | 1990-04-23 |
17,115 clearances in the Orthopedic panel. Data: openFDA.