510(k) K162829 · HRS Plate, Fixation, Bone
Medline UNITE® Ankle Fracture Plating System
| Applicant | Medline Industries, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, Dec 9, 2016 |
| Received | Oct 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162829
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.