Clearance Summary
COPSIOS BONE VOID FILLER (BVF) received FDA 510(k) clearance under submission number K033679, sponsored by Centerpulse Spine-Tech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2004-07-07.
- Submission: K033679
- Applicant / Sponsor: Centerpulse Spine-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3045
- Decision date: 2004-07-07
Classification & Regulation
This clearance is catalogued under FDA product code MQV and 21 CFR 888.3045, within the Orthopedic review panel as a Class II device.