K252958
- 510(k) number
- K252958
- Device name
- METICULY Patient-specific titanium mesh implant
- Applicant
- Meticuly Co., Ltd. TH
- Product code
- GXN — Plate, Cranioplasty, Preformed, Non-Alterable
- Decision date
- 2026-01-14
- Date received
- 2025-09-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252958.pdf
Official FDA record: K252958
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.