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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K152217
Device Name Exactech Vantage Total Ankle System
Applicant
Exactech, Inc.
2320 NW 66th Court
Gainesville,  FL  32653
Applicant Contact SHING JEN TAI
Correspondent
Exactech, Inc.
2320 NW 66th Court
Gainesville,  FL  32653
Correspondent Contact SHING JEN TAI
Regulation Number888.3110
Classification Product Code
HSN  
Date Received08/07/2015
Decision Date 03/10/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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