K190599 is an FDA 510(k) clearance for the Aptis Medical Distal Radio Ulnar Joint Implant. This device is classified as a Prosthesis, Wrist, Hemi-, Ulnar (Class II - Special Controls, product code KXE).
Submitted by Aptis Medical, LLC (Glenview, US). The FDA issued a Cleared decision on May 3, 2019, 56 days after receiving the submission on March 8, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3810.
| 510(k) Number | K190599 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2019 |
| Decision Date | May 03, 2019 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KXE — Prosthesis, Wrist, Hemi-, Ulnar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3810 |