KTW — Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Class II
FDA product code KTW covers "Appliance, Fixation, Nail/Blade/Plate Combination, Single Component", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KTW
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K182285 | paonan biotech co | PK High Tibial Osteotomy Correction System | June 20, 2019 |
| K171606 | advanced orthopaedic solutions, inc. (aos) | AOS Anterolateral Proximal Humeral Plate | June 22, 2017 |
| K170693 | paragon 28 | Phantom Small Bone Intramedullary Nail System | June 19, 2017 |
| K160409 | advanced orthopaedic solutions | AOS Anterolateral Proximal Humeral Plate | March 15, 2016 |
| K122541 | orthofix | ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) | September 20, 2012 |
| K080590 | advanced orthopaedic solutions | AOS PROXIMAL HUMERAL PLATE | May 6, 2008 |
| K080109 | synthes (usa) | SYNTHES (USA) MODULAR BLADE PLATE SYSTEM | March 20, 2008 |
| K062920 | orthofix | ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP | November 13, 2006 |
| K023360 | jeil medical corporation | LEFORTE SYSTEM BONE PLATE | October 25, 2002 |
| K012634 | alliance medical | REPROCESSED EXTERNAL FIXATION DEVICE | June 24, 2002 |
| K012645 | alliance medical | REPROCESSED EBI EXTERNAL FIXATION DEVICES | June 24, 2002 |
| K011815 | synthes (usa) | SYNTHES LCP PROXIMAL HUMERUS PLATES | September 6, 2001 |
| K011458 | synthes (usa) | SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM | August 2, 2001 |
| K010321 | synthes (usa) | MODULAR FOOT SYSTEM - 2.7 MM MODULE | May 2, 2001 |
| K001614 | howmedica osteonics | STRYKER TRAUMA PELVIC SET | August 4, 2000 |
| K001271 | biomet | SAMARCO SPIDER PLATES | July 14, 2000 |
| K992837 | synthes (usa) | 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED L | October 25, 1999 |
| K991405 | turnkey intergration usa | OMNI-FIX, HUMERAL NAIL | June 29, 1999 |
| K990307 | turnkey intergration usa | OMNI-FIX, NAIL SYSTEM | April 1, 1999 |
| K982390 | wrightmedicaltechnologyinc | CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE) | September 14, 1998 |