510(k) K180204 ยท JEY Plate, Bone
CranioMaxillofacial Fixation (CMF) System - CMF Visionare
| Applicant | Visionare, LLC, Fort Myers FL, US |
| Decision | Substantially Equivalent, Dec 28, 2018 |
| Received | Jan 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180204
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.