Clearance Summary
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM received FDA 510(k) clearance under submission number K130309, sponsored by Biomet Microfixation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2013-06-17.
- Submission: K130309
- Applicant / Sponsor: Biomet Microfixation
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5250
- Decision date: 2013-06-17
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.