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510(k) K160879

CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems by Medos International Sàrl — Product Code PML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2016
Date Received
March 30, 2016
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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