Clearance Summary
RPX TITANIUM CEMNT RESTRICTOR received FDA 510(k) clearance under submission number K020344, sponsored by Sulzer Spine-Tech. 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 2002-05-02.
- Submission: K020344
- Applicant / Sponsor: Sulzer Spine-Tech
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2002-05-02
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.