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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 K141740
Device Name INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM
Applicant
Wrightmedicaltechnologyinc
1023 Cherry Rd.
Memphis,  TN  38117
Applicant Contact JEANINE REDDEN
Correspondent
Wrightmedicaltechnologyinc
1023 Cherry Rd.
Memphis,  TN  38117
Correspondent Contact JEANINE REDDEN
Regulation Number888.3110
Classification Product Code
HSN  
Date Received06/27/2014
Decision Date 03/05/2015
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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