KXE — Prosthesis, Wrist, Hemi-, Ulnar Class II
FDA product code KXE covers "Prosthesis, Wrist, Hemi-, Ulnar", a Class II medical device regulated under 21 CFR 888.3810. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KXE
- Device Class
- Class II
- Regulation Number
- 888.3810
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K190599 | aptis medical | Aptis Medical Distal Radio Ulnar Joint Implant | May 3, 2019 |
| K142569 | aptis medical | Aptis Medical Distal Radio Ulnar Joint Implant | April 3, 2015 |
| K112481 | ascension orthopedic | FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT | April 9, 2012 |
| K081025 | remi sciences | ISOELASTICU | November 21, 2008 |
| K082839 | aptis medical | DISTAL RADIO-ULNAR JOINT IMPLANT | October 24, 2008 |
| K061146 | small bone innovations | SBI ULNAR HEAD IMPLANT | July 19, 2006 |
| K053119 | aptis medical | DISTAL RADIO-ULNAR JOINT IMPLANT | December 7, 2005 |
| K052137 | ascension orthopedics | ASCENSION MUH | November 3, 2005 |
| K040497 | aptis medical | DISTAL RADIO-ULNAR JOINT IMPLANT | January 26, 2005 |
| K042902 | stuckenbrock medizintechnik | HERBERT ULNAR HEAD PROSTHESIS SYSTEM | December 27, 2004 |
| K033930 | kapp surgical instrument | KAPP CUSTOM ULNAR HEAD WRIST IMPLANT | July 28, 2004 |
| K020274 | wrightmedicaltechnologyinc | WMT MODULAR ULNAR HEAD IMPLANT | February 22, 2002 |
| K010786 | avanta orthopaedics | ULNAR HEAD IMPLANT | April 11, 2001 |
| K982268 | avanta orthopaedics | ULNAR HEAD IMPLANT | December 4, 1998 |
| K812053 | dow corning corp. healthcare industries materials | SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) | August 18, 1981 |
| K790125 | cutter laboratories | ULNAR HEAD PROTHESIS | February 8, 1979 |