510(k) K253080 ยท HSB Rod, Fixation, Intramedullary And Accessories
AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
| Applicant | Suzhou and Science & Technology Development Corp., Zhangjiagang, CN |
| Decision | Substantially Equivalent, Jun 18, 2026 |
| Received | Sep 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253080
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.