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510(k) K191393

INFINITY Total Ankle System, INBONE Total Ankle System by Wrightmedicaltechnologyinc — Product Code HSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2019
Date Received
May 24, 2019
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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