510(k) K242865 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
| Applicant | Biocomposites, Ltd., Keele, GB |
| Decision | Substantially Equivalent, Jun 12, 2025 |
| Received | Sep 20, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242865
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.