Clearance Summary
CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR received FDA 510(k) clearance under submission number K022615, sponsored by Centerpulse Spine-Tech, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2002-10-29.
- Submission: K022615
- Applicant / Sponsor: Centerpulse Spine-Tech, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2002-10-29
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.