Clearance Summary
MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT received FDA 510(k) clearance under submission number K071927, sponsored by Depuy Spine, A Johnson & Johnson Company. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2007-11-21.
- Submission: K071927
- Applicant / Sponsor: Depuy Spine, A Johnson & Johnson Company
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2007-11-21
Classification & Regulation
This clearance is catalogued under FDA product code NDN and 21 CFR 888.3027, within the Orthopedic review panel as a Class II device.