510(k) K212990 ยท HTN Washer, Bolt Nut
Acumed Ankle Syndesmosis Repair System
| Applicant | Acumed, LLC, Hillsboro OR, US |
| Decision | Substantially Equivalent, Jan 7, 2022 |
| Received | Sep 20, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212990
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.