Clearance Summary
KYPHON (R) HV-R(R) Bone Cement received FDA 510(k) clearance under submission number K150460, sponsored by Medtronic Sofamor Danck USA, 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 2015-04-28.
- Submission: K150460
- Applicant / Sponsor: Medtronic Sofamor Danck USA, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2015-04-28
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.