510(k) K191210 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
Longeviti ClearFit Cranial Implant
| Applicant | Longeviti Neuro Solutions, LLC, Hunt Valley MD, US |
| Decision | Substantially Equivalent, Jan 9, 2020 |
| Received | May 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191210
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.