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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 K140749
Device Name INFINITY TOTAL ANKLE SYSTEM
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
1023 CHERRY ROAD
MEMPHIS,  TN  38117
Applicant Contact JEANINE REDDEN
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
1023 CHERRY ROAD
MEMPHIS,  TN  38117
Correspondent Contact JEANINE REDDEN
Regulation Number888.3110
Classification Product Code
HSN  
Date Received03/25/2014
Decision Date 04/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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