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510(k) K162194

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System by Medicrea International SA — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2016
Date Received
August 5, 2016
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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