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510(k) K201362

CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement by Medtronic — Product Code PML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2020
Date Received
May 22, 2020
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.

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