K240567
- 510(k) number
- K240567
- Device name
- CustomizedBone Service
- Applicant
- Fin-Ceramica Faenza S.P.A. IT
- Product code
- GXN — Plate, Cranioplasty, Preformed, Non-Alterable
- Decision date
- 2024-03-28
- Date received
- 2024-02-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240567.pdf
Official FDA record: K240567
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.