510(k) K112481 ยท KXE Prosthesis, Wrist, Hemi-, Ulnar
FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
| Applicant | Ascension Orthopedic, Austin TX, US |
| Decision | Substantially Equivalent, Apr 9, 2012 |
| Received | Aug 29, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112481
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.