510(k) K191319 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Dunamis Fixation Button System
| Applicant | Dunamis, LLC, Greenville AL, US |
| Decision | Substantially Equivalent, Aug 29, 2019 |
| Received | May 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191319
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.