Product code KTW
- Device name
- Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3030
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182285 | PK High Tibial Osteotomy Correction System | Paonan Biotech Co., Ltd. | 2019-06-20 |
| K171606 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. (Aos) | 2017-06-22 |
| K170693 | Phantom Small Bone Intramedullary Nail System | Paragon 28, Inc. | 2017-06-19 |
| K160409 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. | 2016-03-15 |
| K122541 | ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) | Orthofix Srl | 2012-09-20 |
| K080590 | AOS PROXIMAL HUMERAL PLATE | Advanced Orthopaedic Solutions, Inc. | 2008-05-06 |
| K080109 | SYNTHES (USA) MODULAR BLADE PLATE SYSTEM | Synthes (Usa) | 2008-03-20 |
| K062920 | ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP | Orthofix Srl | 2006-11-13 |
| K023360 | LEFORTE SYSTEM BONE PLATE | Jeil Medical Corporation | 2002-10-25 |
| K012634 | REPROCESSED EXTERNAL FIXATION DEVICE | Alliance Medical, Inc. | 2002-06-24 |
| K012645 | REPROCESSED EBI EXTERNAL FIXATION DEVICES | Alliance Medical Corp. | 2002-06-24 |
| K011815 | SYNTHES LCP PROXIMAL HUMERUS PLATES | Synthes (Usa) | 2001-09-06 |
| K011458 | SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM | Synthes (Usa) | 2001-08-02 |
| K010321 | MODULAR FOOT SYSTEM - 2.7 MM MODULE | Synthes (Usa) | 2001-05-02 |
| K001614 | STRYKER TRAUMA PELVIC SET | Howmedica Osteonics Corp. | 2000-08-04 |
| K001271 | SAMARCO SPIDER PLATES | Biomet, Inc. | 2000-07-14 |
| K992837 | 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP) | Synthes (Usa) | 1999-10-25 |
| K991405 | OMNI-FIX, HUMERAL NAIL | Turnkey Intergration USA, Inc. | 1999-06-29 |
| K990307 | OMNI-FIX, NAIL SYSTEM | Turnkey Intergration USA, Inc. | 1999-04-01 |
| K982390 | CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE) | Wrightmedicaltechnologyinc | 1998-09-14 |
| K971272 | TRAUMA-FIX EXTERNAL FIXATOR | Trend Medical, Inc. | 1997-06-05 |
| K954289 | SYNTHES CANNULATED ANGLE BLADE PLATE | Synthes (Usa) | 1995-11-24 |
| K931686 | MALLEOLAR SCREW | Onyx Medical Corp. | 1994-04-05 |
| K925635 | TORUS EXTERNAL FIXATION SYSTEM | Zimmer, Inc. | 1993-06-01 |
| K924657 | TRUE/FLEX METATARSAL RODS | Applied Osteo Systems, Inc. | 1992-11-24 |
| K914546 | ANGLED BLADE PLATE | Synthes (Usa) | 1991-11-29 |
| K905348 | HANSEN-STREET TYPE INTRAMEDULLARY NAIL | O'Tec Corp. | 1990-12-11 |
| K893928 | LEVTECH SMALL BONE PLATE | Buckman Co., Inc. | 1989-11-03 |
| K870727 | WARSAW ORTHOPEDIC I BONE PLATE | Warsaw Orthopedic, Inc. | 1987-03-09 |
| K862552 | ACROMED ADS BONE NAIL | Buckman Co., Inc. | 1986-09-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809265150527 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265151258 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265151241 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265151234 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265151227 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265151210 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265151203 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150688 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150671 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150602 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150596 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150589 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150572 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150541 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150534 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150206 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150510 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150336 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150329 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150312 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150305 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150299 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150282 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150275 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150268 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150251 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150244 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150237 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150220 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |
| 08809265150213 | Leforte System Bone Plate | Jeil Medical Corporation | 2015-09-24 |