510(k) K172688 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Align Radial Head System
| Applicant | Skeletal Dynamics, LLC, Miami FL, US |
| Decision | Substantially Equivalent, Dec 22, 2017 |
| Received | Sep 6, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K172688
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.