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510(k) K240475

Hintermann Series H2 Total Ankle System by Vilex, LLC — Product Code HSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2024
Date Received
February 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3110
Review Panel
OR
Submission Type

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