510(k) K210616 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
Longeviti PMMA Static Cranial Implant
| Applicant | Longeviti Neuro Solutions, LLC, Hunt Valley MD, US |
| Decision | Substantially Equivalent, Mar 31, 2021 |
| Received | Mar 1, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210616
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.