510(k) K192702 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
| Applicant | Synthes (USA) Products, LLC, West Chester PA, US |
| Decision | Substantially Equivalent, Sep 18, 2020 |
| Received | Sep 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192702
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.