510(k) K170146 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Galaxy UNYCO System
| Applicant | Orthofix Srl, Bussolengo, IT |
| Decision | Substantially Equivalent, Oct 12, 2017 |
| Received | Jan 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170146
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.