510(k) K231188 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
ALIGN Radial Head System
| Applicant | Skeletal Dynamics, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Sep 28, 2023 |
| Received | Apr 26, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231188
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.