510(k) K191997 ยท JEY Plate, Bone
FAICO CMF System
| Applicant | Faico Medical, LLC, Boca Raton FL, US |
| Decision | Substantially Equivalent, Apr 22, 2020 |
| Received | Jul 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191997
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.