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510(k) K202054

Dynex Ring Fixation System, Diametrix Ring Fixation System by Vilex, LLC — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2020
Date Received
July 24, 2020
Clearance Type
Traditional
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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