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510(k) K230938

ARIX Humerus System by Jeil Medical Corporation — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2023
Date Received
April 3, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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