510(k) K193547 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
CustomizedBone Service
| Applicant | Fin-Ceramica Faenza S.P.A., Faenza, IT |
| Decision | Substantially Equivalent, Jan 17, 2020 |
| Received | Dec 20, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193547
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.