510(k) K253130 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Dione PEEK Screw System
| Applicant | ZheJiang Decans Medical Devices Co., Ltd., Jiaxing, CN |
| Decision | Substantially Equivalent, May 27, 2026 |
| Received | Sep 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253130
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.