510(k) K212058 · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Longeviti ClearFit OTS Cranial Implants
| Applicant | Longeviti Neuro Solutions, LLC, Hunt Valley MD, US |
| Decision | Substantially Equivalent, Sep 8, 2021 |
| Received | Jul 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212058
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.