Clearance Summary
CEMSTOP CEMENT RESTRICTOR received FDA 510(k) clearance under submission number K993841, sponsored by Encore Orthopedics, 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 2000-05-04.
- Submission: K993841
- Applicant / Sponsor: Encore Orthopedics, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2000-05-04
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.