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510(k) K173121

Ankle Fusion Plating System by In2bones Sas — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2017
Date Received
September 29, 2017
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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