510(k) K203349 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
Longeviti ClearFit Cranial Implant
| Applicant | Longeviti Neuro Solutions, LLC, Hunt Valley MD, US |
| Decision | Substantially Equivalent, Dec 16, 2020 |
| Received | Nov 13, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203349
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.