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510(k) K183343

Vantage Total Ankle Flat Cut Talar Components by Exactech, Inc. — Product Code HSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2019
Date Received
December 3, 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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