FDA Product Code
FDA Product Code KXE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3810
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K190599 | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | 2019-05-03 | Traditional | PDF ↗ |
| K142569 | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | 2015-04-03 | Traditional | PDF ↗ |
| K112481 | FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT | Ascension Orthopedic | 2012-04-09 | Traditional | PDF ↗ |
| K081025 | ISOELASTICU | Remi Sciences, Inc. | 2008-11-21 | Traditional | PDF ↗ |
| K082839 | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | 2008-10-24 | Special | PDF ↗ |
| K061146 | SBI ULNAR HEAD IMPLANT | Small Bone Innovations, Inc. | 2006-07-19 | Special | PDF ↗ |
| K053119 | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | 2005-12-07 | Special | PDF ↗ |
| K052137 | ASCENSION MUH | Ascension Orthopedics, Inc. | 2005-11-03 | Traditional | PDF ↗ |
| K040497 | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | 2005-01-26 | Traditional | PDF ↗ |
| K042902 | HERBERT ULNAR HEAD PROSTHESIS SYSTEM | Stuckenbrock Medizintechnik GmbH | 2004-12-27 | Traditional | PDF ↗ |
| K033930 | KAPP CUSTOM ULNAR HEAD WRIST IMPLANT | Kapp Surgical Instrument, Inc. | 2004-07-28 | Traditional | PDF ↗ |
| K020274 | WMT MODULAR ULNAR HEAD IMPLANT | Wrightmedicaltechnologyinc | 2002-02-22 | Traditional | PDF ↗ |
| K010786 | ULNAR HEAD IMPLANT | Avanta Orthopaedics, Inc. | 2001-04-11 | Special | PDF ↗ |
| K982268 | ULNAR HEAD IMPLANT | Avanta Orthopaedics, Inc. | 1998-12-04 | Traditional | PDF ↗ |
| K812053 | SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) | Dow Corning Corp. Healthcare Industries Materials | 1981-08-18 | Traditional | PDF ↗ |
| K790125 | ULNAR HEAD PROTHESIS | Cutter Laboratories, Inc. | 1979-02-08 | Traditional | PDF ↗ |
Product code KXE · Class II · Orthopedic. Data: openFDA.