510(k) K243634 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Maxx Libertas Bipolar Hip Head (Bipolar Hip)
| Applicant | Maxx Orthopedics, Inc., Norristown PA, US |
| Decision | Substantially Equivalent, Aug 25, 2025 |
| Received | Nov 25, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243634
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.