510(k) K132735 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
AXIA RADIAL HEAD SYSTEM
| Applicant | Imds (Innovative MEdical Device Systems) - Leis ME, Orlando FL, US |
| Decision | Substantially Equivalent, Jan 7, 2014 |
| Received | Sep 3, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132735
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.