Clearance Summary
CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM received FDA 510(k) clearance under submission number K101235, sponsored by Neos Surgery S.L. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2010-10-25.
- Submission: K101235
- Applicant / Sponsor: Neos Surgery S.L
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5250
- Decision date: 2010-10-25
Classification & Regulation
This clearance is catalogued under FDA product code GXR and 21 CFR 882.5250, within the Neurology review panel as a Class II device.