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510(k) K171938

KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set by Medtronic — Product Code PML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2017
Date Received
June 28, 2017
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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