Clearance Summary
HARRIS CEMENT RESTRICTOR received FDA 510(k) clearance under submission number K810353, sponsored by Cintor Orthopaedic Div.. 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 1981-02-23.
- Submission: K810353
- Applicant / Sponsor: Cintor Orthopaedic Div.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 1981-02-23
Classification & Regulation
This clearance is catalogued under FDA product code LZN and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.