510(k) K183236 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
Rotium Bioresorbable Wick
| Applicant | Nanofiber Solutions, LLC, Hilliard OH, US |
| Decision | Substantially Equivalent, Mar 11, 2019 |
| Received | Nov 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183236
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.