Clearance Summary
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT received FDA 510(k) clearance under submission number K080507, sponsored by Ceremed , Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2008-04-21.
- Submission: K080507
- Applicant / Sponsor: Ceremed , Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3500
- Decision date: 2008-04-21
Classification & Regulation
This clearance is catalogued under FDA product code KKY and 21 CFR 878.3500, within the General, Plastic Surgery review panel as a Class II device.