510(k) K203385 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
TenoTac Soft Tissue Fixation System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Feb 11, 2021 |
| Received | Nov 18, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203385
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.