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510(k) K140417

DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM by Medtronic Sofamor Danek, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2014
Date Received
February 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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