510(k) K191148
K191148 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek USA, Inc. for the device "Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set". The FDA issued a decision of Substantially Equivalent on September 12, 2019. The device falls under product code PML (Bone Cement, Posterior Screw Augmentation), a Class II device regulated under 21 CFR 888.3027. Medtronic Sofamor Danek USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2019
- Date Received
- April 30, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bone Cement, Posterior Screw Augmentation
- Device Class
- Class II
- Regulation Number
- 888.3027
- Review Panel
- OR
- Submission Type
The device is intended to augment the fixation of screws in a posterior spinal system construct.