510(k) K220357 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
MedCAD AccuShape Titanium Patient-Specific Cranial Implant
| Applicant | Medcad, Dallas TX, US |
| Decision | Substantially Equivalent, Aug 26, 2022 |
| Received | Feb 8, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220357
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.