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510(k) K221787

Auxein's DHS/DCS Plate System by Auxein Medical Private Limited — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2023
Date Received
June 21, 2022
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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