510(k) K212640 · HRS Plate, Fixation, Bone
Stratum® Ankle Fusion Plating System
| Applicant | Nextremity Solutions, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 18, 2021 |
| Received | Aug 20, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212640
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.