510(k) K180213 ยท HRS Plate, Fixation, Bone
Titanium TomoFix Medial High Tibia Plate Anatomical
| Applicant | Synthes (USA) Products, LLC, West Chester PA, US |
| Decision | Substantially Equivalent, Oct 19, 2018 |
| Received | Jan 25, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180213
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.