510(k) K260536 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
| Applicant | Depuy Ireland UC, Ringaskiddy, IE |
| Decision | Substantially Equivalent, May 15, 2026 |
| Received | Feb 17, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260536
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.