Clearance Summary
TITANIUM CEMENT RESTRICTOR (TCR) received FDA 510(k) clearance under submission number K003718, sponsored by Medtronic Sofamor Danek, 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 2001-02-14.
- Submission: K003718
- Applicant / Sponsor: Medtronic Sofamor Danek, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2001-02-14
Classification & Regulation
This clearance is catalogued under FDA product code JDK and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.