510(k) K223589 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Grappler Suture Anchor R3FLEX IOL System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Mar 3, 2023 |
| Received | Dec 1, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223589
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.