510(k) clearance
CraniUS Plate
- 510(k) number
- K262874
- Applicant
- CraniUS, LLC
- Decision date
- Sep 11, 2026
- Date received
- Aug 14, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- GWO
- Device type
- Plate, Cranioplasty, Preformed, Alterable
- Device class
- Class II
- Regulation
- 21 CFR 882.5320
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Baltimore, MD, US