Clearance Summary
Longeviti ClearFit OTS Cranial Implants received FDA 510(k) clearance under submission number K212058, sponsored by Longeviti Neuro Solutions, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2021-09-08.
- Submission: K212058
- Applicant / Sponsor: Longeviti Neuro Solutions, LLC
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5330
- Decision date: 2021-09-08
Classification & Regulation
This clearance is catalogued under FDA product code GXN and 21 CFR 882.5330, within the Neurology review panel as a Class II device.