FDA Product Code
FDA Product Code KTW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3030
510(k) Clearances — 38 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K182285 | PK High Tibial Osteotomy Correction System | Paonan Biotech Co., Ltd. | 2019-06-20 | Traditional | PDF ↗ |
| K171606 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. (Aos) | 2017-06-22 | Special | PDF ↗ |
| K170693 | Phantom Small Bone Intramedullary Nail System | Paragon 28, Inc. | 2017-06-19 | Traditional | PDF ↗ |
| K160409 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. | 2016-03-15 | Special | PDF ↗ |
| K122541 | ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) | Orthofix Srl | 2012-09-20 | Special | PDF ↗ |
| K080590 | AOS PROXIMAL HUMERAL PLATE | Advanced Orthopaedic Solutions, Inc. | 2008-05-06 | Traditional | PDF ↗ |
| K080109 | SYNTHES (USA) MODULAR BLADE PLATE SYSTEM | Synthes (Usa) | 2008-03-20 | Traditional | PDF ↗ |
| K062920 | ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP | Orthofix Srl | 2006-11-13 | Traditional | PDF ↗ |
| K023360 | LEFORTE SYSTEM BONE PLATE | Jeil Medical Corporation | 2002-10-25 | Traditional | PDF ↗ |
| K012634 | REPROCESSED EXTERNAL FIXATION DEVICE | Alliance Medical, Inc. | 2002-06-24 | Traditional | PDF ↗ |
| K012645 | REPROCESSED EBI EXTERNAL FIXATION DEVICES | Alliance Medical Corp. | 2002-06-24 | Traditional | PDF ↗ |
| K011815 | SYNTHES LCP PROXIMAL HUMERUS PLATES | Synthes (Usa) | 2001-09-06 | Traditional | PDF ↗ |
| K011458 | SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM | Synthes (Usa) | 2001-08-02 | Abbreviated | PDF ↗ |
| K010321 | MODULAR FOOT SYSTEM - 2.7 MM MODULE | Synthes (Usa) | 2001-05-02 | Traditional | PDF ↗ |
| K001614 | STRYKER TRAUMA PELVIC SET | Howmedica Osteonics Corp. | 2000-08-04 | Traditional | PDF ↗ |
| K001271 | SAMARCO SPIDER PLATES | Biomet, Inc. | 2000-07-14 | Traditional | PDF ↗ |
| K992837 | 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP) | Synthes (Usa) | 1999-10-25 | Traditional | PDF ↗ |
| K991405 | OMNI-FIX, HUMERAL NAIL | Turnkey Intergration USA, Inc. | 1999-06-29 | Traditional | PDF ↗ |
| K990307 | OMNI-FIX, NAIL SYSTEM | Turnkey Intergration USA, Inc. | 1999-04-01 | Traditional | PDF ↗ |
| K982390 | CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE) | Wrightmedicaltechnologyinc | 1998-09-14 | Traditional | PDF ↗ |
| K971272 | TRAUMA-FIX EXTERNAL FIXATOR | Trend Medical, Inc. | 1997-06-05 | Traditional | PDF ↗ |
| K954289 | SYNTHES CANNULATED ANGLE BLADE PLATE | Synthes (Usa) | 1995-11-24 | Traditional | PDF ↗ |
| K931686 | MALLEOLAR SCREW | Onyx Medical Corp. | 1994-04-05 | Traditional | PDF ↗ |
| K925635 | TORUS EXTERNAL FIXATION SYSTEM | Zimmer, Inc. | 1993-06-01 | Traditional | PDF ↗ |
| K924657 | TRUE/FLEX METATARSAL RODS | Applied Osteo Systems, Inc. | 1992-11-24 | Traditional | PDF ↗ |
| K914546 | ANGLED BLADE PLATE | Synthes (Usa) | 1991-11-29 | Traditional | PDF ↗ |
| K905348 | HANSEN-STREET TYPE INTRAMEDULLARY NAIL | O'Tec Corp. | 1990-12-11 | Traditional | PDF ↗ |
| K893928 | LEVTECH SMALL BONE PLATE | Buckman Co., Inc. | 1989-11-03 | Traditional | PDF ↗ |
| K870727 | WARSAW ORTHOPEDIC I BONE PLATE | Warsaw Orthopedic, Inc. | 1987-03-09 | Traditional | PDF ↗ |
| K862552 | ACROMED ADS BONE NAIL | Buckman Co., Inc. | 1986-09-02 | Traditional | PDF ↗ |
| K862279 | EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM | Orthospec, Inc. | 1986-07-25 | Traditional | PDF ↗ |
| K851349 | LERE NAIL & PLATE COMBIN. ONE PIECE FORGED | Medicalex | 1985-05-29 | Traditional | PDF ↗ |
| K843553 | BONE PLATES | Mecron Medical Products, Inc. | 1984-10-01 | Traditional | PDF ↗ |
| K843554 | BONE SCREWS | Mecron Medical Products, Inc. | 1984-10-01 | Traditional | PDF ↗ |
| K821566 | ORTHOPEDIC FIXATION DEVICES | Howmedica Corp. | 1982-06-03 | Traditional | PDF ↗ |
| K813340 | HIP PIN | The Deca Co. | 1982-01-29 | Traditional | PDF ↗ |
| K792291 | SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES | Synthes (Usa) | 1979-12-06 | Traditional | PDF ↗ |
| K781762 | COMPRESSION HIP SCREW SYSTEM | Howmedica Corp. | 1978-12-20 | Traditional | PDF ↗ |
Product code KTW · Class II · Orthopedic. Data: openFDA.