510(k) K233592 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
BioPoly Radial Head Implant
| Applicant | BioPoly, LLC, Fort Wayne IN, US |
| Decision | Substantially Equivalent, Mar 13, 2024 |
| Received | Nov 8, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233592
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.