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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 K181557
Device Name INFINITY Total Ankle System
Applicant
Wrightmedicaltechnologyinc
1023 Cherry Rd.
Memphis,  TN  38117
Applicant Contact Tara Conrad
Correspondent
Wrightmedicaltechnologyinc
1023 Cherry Rd.
Memphis,  TN  38117
Correspondent Contact Tara Conrad
Regulation Number888.3110
Classification Product Code
HSN  
Date Received06/13/2018
Decision Date 08/09/2018
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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