510(k) K182898 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
TenoTac Soft Tissue Fixation System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Jan 14, 2019 |
| Received | Oct 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182898
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.