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510(k) K181557

INFINITY Total Ankle System by Wrightmedicaltechnologyinc — Product Code HSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2018
Date Received
June 13, 2018
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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