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510(k) K141123

ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM by Alliance Partners, LLC — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2015
Date Received
May 1, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Alterable
Device Class
Class II
Regulation Number
882.5320
Review Panel
NE
Submission Type

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