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510(k) K160830

Integra External Fixation System by Ascension Orthopedics — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2016
Date Received
March 25, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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