Clearance Summary
Biopor Porous Polyethylene Implants received FDA 510(k) clearance under submission number K161446, sponsored by Ceremed , 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 2016-09-27.
- Submission: K161446
- Applicant / Sponsor: Ceremed , Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5320
- Decision date: 2016-09-27
Classification & Regulation
This clearance is catalogued under FDA product code GWO and 21 CFR 882.5320, within the Neurology review panel as a Class II device.