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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 K171067
Device Name INVISION Total Ankle Revision System
Applicant
Wrightmedicaltechnologyinc
1023 Cherry Rd.
Memphis,  TN  38117
Applicant Contact Val Myles
Correspondent
Wrightmedicaltechnologyinc
1023 Cherry Rd.
Memphis,  TN  38117
Correspondent Contact Val Myles
Regulation Number888.3110
Classification Product Code
HSN  
Date Received04/10/2017
Decision Date 09/11/2017
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
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