510(k) K213895 ยท HRS Plate, Fixation, Bone
Distal Humerus Plating System
| Applicant | Skeletal Dynamics, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jan 13, 2022 |
| Received | Dec 14, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213895
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.