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510(k) K212044

TrueLok Evo by Orthofix Srl — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2021
Date Received
June 30, 2021
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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