510(k) K253675 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
OsteoRemedies Hip Spacer System
| Applicant | Osteoremedies, LLC, Germantown TN, US |
| Decision | Substantially Equivalent, Dec 23, 2025 |
| Received | Nov 21, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253675
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.