510(k) K212391 ยท GWO Plate, Cranioplasty, Preformed, Alterable
MCI-Neuro Fixation System
| Applicant | Mci Medical Concept Innovation, Inc., Sunrise FL, US |
| Decision | Substantially Equivalent, Oct 21, 2022 |
| Received | Aug 2, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212391
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.