510(k) K253046 ยท HSB Rod, Fixation, Intramedullary And Accessories
HERA Interlocking Intramedullary Nailing System
| Applicant | ZheJiang Decans Medical Devices Co., Ltd., Jiaxing, CN |
| Decision | Substantially Equivalent, Jun 16, 2026 |
| Received | Sep 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253046
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.