Clearance Summary
Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set received FDA 510(k) clearance under submission number K191148, sponsored by Medtronic Sofamor Danek 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 2019-09-12.
- Submission: K191148
- Applicant / Sponsor: Medtronic Sofamor Danek USA, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2019-09-12
Classification & Regulation
This clearance is catalogued under FDA product code PML and 21 CFR 888.3027, within the Orthopedic review panel as a Class II device.