Clearance Summary
BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM received FDA 510(k) clearance under submission number K053213, sponsored by Berkeley Advanced Biomaterials, 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 2006-07-06.
- Submission: K053213
- Applicant / Sponsor: Berkeley Advanced Biomaterials, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3045
- Decision date: 2006-07-06
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.