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510(k) K193554

APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System by Medartis AG — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2020
Date Received
December 20, 2019
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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