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510(k) K101353

GOLDEN GATE ANTERIOR PLATE SYSTEM by Ulrich GmbH & Co. KG — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2011
Date Received
May 14, 2010
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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