510(k) K243665 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)
| Applicant | ZheJiang Decans Medical Devices Co., Ltd., Jiaxing, CN |
| Decision | Substantially Equivalent, Jan 31, 2025 |
| Received | Nov 27, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243665
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.