510(k) K210099 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
Meticuly Patient-Specific Titanium Mesh Implant
| Applicant | Meticuly Co., Ltd., Muang Nonthaburi, TH |
| Decision | Substantially Equivalent, Dec 21, 2021 |
| Received | Jan 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210099
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.