Clearance Summary
STATIC CRANIOPLASTY ORTHOSIS received FDA 510(k) clearance under submission number K063098, sponsored by Boston Brace Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2007-04-11.
- Submission: K063098
- Applicant / Sponsor: Boston Brace Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5970
- Decision date: 2007-04-11
Classification & Regulation
This clearance is catalogued under FDA product code OAN and 21 CFR 882.5970, within the Neurology review panel as a Class II device.