K261058
- 510(k) number
- K261058
- Device name
- CraniUS Plate
- Applicant
- CraniUS, LLC MD · US
- Product code
- GWO — Plate, Cranioplasty, Preformed, Alterable
- Decision date
- 2026-07-29
- Date received
- 2026-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K261058.pdf
Official FDA record: K261058
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.