510(k) K192162 ยท GXR Cover, Burr Hole
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
| Applicant | Neurovention, LLC, Daytona Beach FL, US |
| Decision | Substantially Equivalent, Mar 13, 2020 |
| Received | Aug 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192162
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.