510(k) K231920 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
Longeviti ClearFit OTS Cranial Implant
| Applicant | Longeviti Neuro Solutions, LLC, Hunt Valley MD, US |
| Decision | Substantially Equivalent, Nov 9, 2023 |
| Received | Jun 29, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231920
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.