510(k) K082839 ยท KXE Prosthesis, Wrist, Hemi-, Ulnar
DISTAL RADIO-ULNAR JOINT IMPLANT
| Applicant | Aptis Medical, LLC, Glenview KY, US |
| Decision | Substantially Equivalent, Oct 24, 2008 |
| Received | Sep 26, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082839
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.