510(k) K253155 ยท HSB Rod, Fixation, Intramedullary And Accessories
Fule Metallic Lockable Intramedullary Nail Systems
| Applicant | Beijing Fule Science & Technology Development Co., Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Jun 17, 2026 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253155
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.