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510(k) K252826

ARIX Femur Nail System by Jeil Medical Corporation — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2025
Date Received
September 5, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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