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510(k) K110700

ASCENSION ATLAS HUMERAL PLATING SYSTEM by Ascension Orthopedics, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2011
Date Received
March 14, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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