Product code KXE
- Device name
- Prosthesis, Wrist, Hemi-, Ulnar
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3810
- 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 |
|---|---|---|---|
| K190599 | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | 2019-05-03 |
| K142569 | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | 2015-04-03 |
| K112481 | FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT | Ascension Orthopedic | 2012-04-09 |
| K081025 | ISOELASTICU | Remi Sciences, Inc. | 2008-11-21 |
| K082839 | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | 2008-10-24 |
| K061146 | SBI ULNAR HEAD IMPLANT | Small Bone Innovations, Inc. | 2006-07-19 |
| K053119 | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | 2005-12-07 |
| K052137 | ASCENSION MUH | Ascension Orthopedics, Inc. | 2005-11-03 |
| K040497 | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | 2005-01-26 |
| K042902 | HERBERT ULNAR HEAD PROSTHESIS SYSTEM | Stuckenbrock Medizintechnik GmbH | 2004-12-27 |
| K033930 | KAPP CUSTOM ULNAR HEAD WRIST IMPLANT | Kapp Surgical Instrument, Inc. | 2004-07-28 |
| K020274 | WMT MODULAR ULNAR HEAD IMPLANT | Wrightmedicaltechnologyinc | 2002-02-22 |
| K010786 | ULNAR HEAD IMPLANT | Avanta Orthopaedics, Inc. | 2001-04-11 |
| K982268 | ULNAR HEAD IMPLANT | Avanta Orthopaedics, Inc. | 1998-12-04 |
| K812053 | SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) | Dow Corning Corp. Healthcare Industries Materials | 1981-08-18 |
| K790125 | ULNAR HEAD PROTHESIS | Cutter Laboratories, Inc. | 1979-02-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885556826539 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826249 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826232 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826225 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826218 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826201 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826195 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826614 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826607 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826591 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826584 | First Choice Modular Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826577 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826560 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826553 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826546 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826522 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826515 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826508 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826492 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826485 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826478 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556826461 | First Choice Partial Ulnar Head Implant | Smith & Nephew, Inc. | 2022-12-21 |
| B013DRUJRPLP300 | Scheker Prosthesis | APTIS MEDICAL, LLC | 2019-05-14 |
| B013DRUJRPLP200 | Scheker Prosthesis | APTIS MEDICAL, LLC | 2019-05-14 |
| 10381780234951 | Integra® First Choice® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236757 | Integra® First Choice® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236740 | Integra® First Choice® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236733 | Integra® First Choice® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236726 | Integra® First Choice® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236719 | Integra® First Choice® | Ascension Orthopedics, Inc. | 2016-08-15 |