Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 33
- Latest Decision
- 2001-09-28
Clearances · page 122 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K012114 | SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM | Synthes (Usa) | HRS | Class II | 2001-09-28 |
| K003780 | VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek, Inc. | KWP | Class II | 2001-09-28 |
| K012270 | STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM | Stryker Endoscopy | JDW | Class II | 2001-09-28 |
| K012062 | PF2 | Fixano SA | KTT | Class II | 2001-09-27 |
| K012078 | RADIOFIX | Fixano SA | KTT | Class II | 2001-09-27 |
| K012866 | THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 | Implex Corp. | JWH | Class II | 2001-09-26 |
| K012870 | XIA STAINLESS STEEL SYSTEM | Howmedica Osteonics Corp. | KWP | Class II | 2001-09-24 |
| K012190 | AOS MODULAR FEMORAL NAIL | Advanced Orthopaedic Solutions, Inc. | HSB | Class II | 2001-09-24 |
| K000122 | COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX) | Neucoll, Inc. | MQV | Class II | 2001-09-20 |
| K011954 | SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE | Sulzer Orthopedics, Inc. | HSX | Class II | 2001-09-19 |
| K012334 | CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 | Bionx Implants, Inc. | MAI | Class II | 2001-09-19 |
| K012125 | OPUS MAGNUM ANCHOR & INSERTER | Opus Medical, Inc. | HTY | Class II | 2001-09-17 |
| K010827 | COPELAND MB/HA RESURFACING HUMERAL HEADS | Biomet Orthopedics, Inc. | HSD | Class II | 2001-09-14 |
| K010657 | COPELAND MB RESURFACING HUMERAL HEADS | Biomet Manufacturing, Inc. | HSD | Class II | 2001-09-14 |
| K012871 | SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177 | Interpore Cross Intl. | KWP | Class II | 2001-09-13 |
| K011857 | SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM | Synthes (Usa) | HSB | Class II | 2001-09-12 |
| K010303 | ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE | Artscan Medical Innovations | NGR | Class II | 2001-09-11 |
| K011810 | ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING | Depuy, Inc. | KRO | Class II | 2001-09-07 |
| K011836 | MPF ACETABULAR CUP | Plus Orthopedics | LZO | Class II | 2001-09-07 |
| K011875 | MODIFICATION TO THE TAC' PIN | New Deal, S.A. | JDW | Class II | 2001-09-06 |
| K011815 | SYNTHES LCP PROXIMAL HUMERUS PLATES | Synthes (Usa) | KTW | Class II | 2001-09-06 |
| K011821 | MODIFICATION TO THE I.C.O.S SCREW | New Deal, S.A. | HWC | Class II | 2001-09-06 |
| K011774 | R120 MODULAR TOTAL HIP SYSTEM | Osteoimplant Technology, Inc. | JDI | Class II | 2001-09-05 |
| K011912 | MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000 | Axya Medical, Inc. | MBI | Class II | 2001-08-31 |
| K012162 | STRYKER PLATING SYSTEM BASIC FRAGMENT SET | Howmedica Osteonics Corp. | HRS | Class II | 2001-08-31 |
| K012507 | THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX) | Implex Corp. | LPH | Class II | 2001-08-30 |
| K011716 | THE UNI-CLIP STAPLE | New Deal, S.A. | JDR | Class II | 2001-08-30 |
| K012493 | ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 | Exactech, Inc. | JDI | Class II | 2001-08-29 |
| K003198 | VULCAN TAC PROBES, MODEL 911XXX | Oratec Interventions, Inc. | HRX | Class II | 2001-08-29 |
| K011827 | ORTELIUS 800 | Orthoscan , Ltd. | KQX | Class I | 2001-08-28 |
| K011715 | MACROPORE IB RESORBABLE PLUG | Macropore Biosurgery, Inc. | JDI | Class II | 2001-08-27 |
| K012161 | FLEX-NAILS | Fixano SA | HTY | Class II | 2001-08-24 |
| K011946 | THE SPIN SNAP-OFF SCREW | New Deal, S.A. | HWC | Class II | 2001-08-24 |
| K012305 | MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM | Sulzer Spine-Tech | KWQ | Class II | 2001-08-22 |
| K010635 | INTERLOK / HA COPELAND RESURFACING HEADS | Biomet, Inc. | MBF | Class II | 2001-08-20 |
| K012280 | TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 | Triage Medical, Inc. | HWC | Class II | 2001-08-17 |
| K012273 | SPIRAL RADIUS 90-D SST SYSTEM | United States Surgical, A Division of Tyco Healthc | MNH | Class II | 2001-08-15 |
| K011603 | VHS PEDIATRIC HIP SCREW SYSTEM | Walter Abendschein, M.D. | KTT | Class II | 2001-08-15 |
| K012212 | MODIFICATION TO AEQUALIS SHOULDER SYSTEM | Tornier | KWS | Class II | 2001-08-15 |
| K012348 | MAXIM RPG PS FEMORAL COMPONENT | Biomet, Inc. | JWH | Class II | 2001-08-15 |
| K011504 | BAUMER LOCKING NAIL | Baumer, S.A | JDS | Class II | 2001-08-14 |
| K011978 | SYNTHES LCP PROXIMAL TIBIA PLATE | Synthes (Usa) | HRS | Class II | 2001-08-09 |
| K011807 | SCS CLARIS SPINAL SCREWS, TYPES V,G,E | Ortho Tec, LLC | MNI | Class II | 2001-08-07 |
| K011460 | WUJIN #3 TIBIAL BONE PLATE | Biopro, Inc. | HRS | Class II | 2001-08-07 |
| K011459 | WUJIN #3 FEMORAL BONE PLATE | Biopro, Inc. | HRS | Class II | 2001-08-07 |
| K011102 | ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM | Aesculap, Inc. | HWC | Class II | 2001-08-03 |
| K010345 | KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS | KARL STORZ Endoscopy-America, Inc. | HRX | Class II | 2001-08-03 |
| K011386 | EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE | Ebi, L.P. | MQV | Class II | 2001-08-03 |
| K010530 | GEO STRUCTURE | Interpore Cross Intl. | MQP | Class II | 2001-08-03 |
| K011458 | SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM | Synthes (Usa) | KTW | Class II | 2001-08-02 |
| K010738 | CANNULATED PLUS SCREW SYSTEM | Orthomatrix, Inc. | HWC | Class II | 2001-08-01 |
| K011495 | ARTHREX BIO-POST AND WASHER | Arthrex, Inc. | MAI | Class II | 2001-08-01 |
| K012158 | MODIFICATION TO: LONG LENGTH GAMMA NAIL | Howmedica Osteonics Corp. | HSB | Class II | 2001-08-01 |
| K012175 | PASS SPINAL SYSTEM | Encore Orthopedics, Inc. | MNI | Class II | 2001-07-31 |
| K011489 | SUMMIT DUOFIX HIP PROSTHESIS | DePuy Orthopaedics, Inc. | LPH | Class II | 2001-07-31 |
| K012251 | OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES | Exactech, Inc. | JWH | Class II | 2001-07-31 |
| K011354 | HIGH TIBIAL OSTEOTOMY PLATING SYSTEM | Dj Orthopedics, LLC | HRS | Class II | 2001-07-31 |
| K011522 | RESORBABLE BONE PINS | Biomet, Inc. | HTY | Class II | 2001-07-31 |
| K011334 | SYNTHES CURVED RECONSTRUCTION PLATE | Synthes (Usa) | HRS | Class II | 2001-07-27 |
| K011335 | SYNTHS ONE-THIRD TUBULAR DCL PLATE | Synthes (Usa) | HRS | Class II | 2001-07-27 |
| K012095 | THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX) | Implex Corp. | JWH | Class II | 2001-07-26 |
| K012024 | EBI XFIX DFS SYSTEM | Ebi, L.P. | KTT | Class II | 2001-07-25 |
| K011830 | TRI-FIX SPINAL FIXATION SYSTEM | Endius, Inc. | KWP | Class II | 2001-07-23 |
| K011319 | STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX | Stryker Endoscopy | JDW | Class II | 2001-07-20 |
| K010911 | MACROPORE OS SPINAL SYSTEM | Macropore Biosurgery, Inc. | KWQ | Class II | 2001-07-20 |
| K003831 | ARTHROSCOPES | Global Endoscopy, Inc. | HRX | Class II | 2001-07-20 |
| K012027 | MODIFICATION TO XIA SPINE SYSTEM | Howmedica Osteonics | MNH | Class II | 2001-07-20 |
| K012019 | COLOR BUFFED (CB) DDH FEMORAL STEM | Biomet, Inc. | JDI | Class II | 2001-07-20 |
| K011118 | NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM | Osteomedics | HRS | Class II | 2001-07-20 |
| K011904 | NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) | Implex Corp. | JWH | Class II | 2001-07-19 |
| K011969 | SYNTHES CERVIFIX SYSTEM | Synthes (Usa) | KWP | Class II | 2001-07-19 |
| K004003 | PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30 | Interpore Cross Intl. | MQV | Class II | 2001-07-19 |
| K003709 | SURGICAL DYNAMICS MESH CAGE SYSTEM | United States Surgical, A Division of Tyco Healthc | MQP | Class II | 2001-07-18 |
| K012026 | TRIDENT ALL POLY CUP | Howmedica Osteonics Corp. | JDI | Class II | 2001-07-18 |
| K011455 | BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER | Biomet, Inc. | JDI | Class II | 2001-07-18 |
| K010681 | SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM | Depuyacromed | KWP | Class II | 2001-07-18 |
| K012000 | 1.5MM BONE FIXATION KIT | Bionx Implants, Ltd. | HWC | Class II | 2001-07-18 |
| K012001 | SMARTSCREW | Bionx Implants, Ltd. | HWC | Class II | 2001-07-18 |
| K011076 | LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW | Walter Lorenz Surgical, Inc. | HRS | Class II | 2001-07-16 |
| K011976 | OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION) | Exactech, Inc. | JWH | Class II | 2001-07-16 |
| K010051 | POLY-TAPES WITH THE FASTLOK FIXATION DEVICE | Xiros Plc | JDR | Class II | 2001-07-13 |
| K004043 | METAL TRANSCEND ARTICULATION SYSTEM | Wrightmedicaltechnologyinc | JDL | Class III | 2001-07-13 |
| K011948 | HOFFMAN II HYBRID RING CLAMP | Howmedica Osteonics Corp. | LXT | Class II | 2001-07-13 |
| K011942 | AEQUALIS PRESS-FIT SHOULDER PROSTHESIS | Tornier | HSD | Class II | 2001-07-13 |
| K011910 | IN-FAST BONE SCREW SYSTEM | American Medical Systems, Inc. | HWC | Class II | 2001-07-13 |
| K003954 | STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT | Biocomposites, Ltd. | MQV | Class II | 2001-07-12 |
| K011129 | SIGN IM NAIL | Sign, Inc. | HSB | Class II | 2001-07-11 |
| K003823 | SCS DT-02 TRANSVERSE CONNECTOR | Ortho Tec, LLC | KWP | Class II | 2001-07-11 |
| K011138 | OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT | Biomet, Inc. | HRY | Class II | 2001-07-10 |
| K011099 | GLOBAL FX POROUS-COATED HUMERAL STEM | DePuy Orthopaedics, Inc. | MBF | Class II | 2001-07-06 |
| K010964 | AUTO-DRIVE LAG SCREW SYSTEM | Osteomed Corp. | HWC | Class II | 2001-07-05 |
| K011170 | SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE | Synthes (Usa) | HRS | Class II | 2001-07-05 |
| K011719 | PLUS CANCELLOUS BONE SCREWS | Plus Orthopedics | HWC | Class II | 2001-07-02 |
| K011110 | M2A ACETABULAR SYSTEM | Biomet, Inc. | KWA | Class III | 2001-07-02 |
| K011711 | MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM | Ebi, L.P. | KTT | Class II | 2001-06-29 |
| K011083 | ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND | Arthrocare Corp. | HRX | Class II | 2001-06-28 |
| K011047 | GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT | DePuy Orthopaedics, Inc. | MBF | Class II | 2001-06-28 |
| K011643 | SCORPIO CR SUPERFLEX TIBIAL INSERT | Howmedica Osteonics Corp. | JWH | Class II | 2001-06-28 |
| K011034 | SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM | Synthes (Usa) | KTT | Class II | 2001-06-27 |
| K003182 | ORTHOGENESIS LPS SYSTEM | Depuy, Inc. | JWH | Class II | 2001-06-27 |
17,115 clearances in the Orthopedic panel. Data: openFDA.