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510(k) K193067

The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System by Wrightmedicaltechnologyinc — Product Code HSN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 8, 2020
Date Received: November 4, 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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