510(k) K183690 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Tenodesis Screw System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Mar 1, 2019 |
| Received | Dec 31, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183690
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.