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510(k) K213905

ONX Large External Fixation System by Orthonovis, Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2022
Date Received
December 14, 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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