510(k) K252958 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
METICULY Patient-specific titanium mesh implant
| Applicant | Meticuly Co., Ltd., Bangkok, TH |
| Decision | Substantially Equivalent, Jan 14, 2026 |
| Received | Sep 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252958
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.