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510(k) K231343

Redemption Duo Hindfoot Nail System by Vilex, LLC — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2024
Date Received
May 9, 2023
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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