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510(k) K100925

ASCENSION ANKLE FUSION NAIL SYSTEM by Ascension Orthopedics, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2010
Date Received
April 2, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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