K252251
- 510(k) number
- K252251
- Device name
- EASYMADE-TI
- Applicant
- CG Bio Co., Ltd. KR
- Product code
- GXN — Plate, Cranioplasty, Preformed, Non-Alterable
- Decision date
- 2026-04-09
- Date received
- 2025-07-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K252251.pdf
Official FDA record: K252251
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.