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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shoulder prosthesis, reverse configuration
510(k) Number K141029
Device Name TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM
Applicant
TORNIER, INC.
10801 Nesbitt Avenue South
Bloomington,  MN  55437
Applicant Contact KRISTINE TUCKER
Correspondent
TORNIER, INC.
10801 Nesbitt Avenue South
Bloomington,  MN  55437
Correspondent Contact KRISTINE TUCKER
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received04/22/2014
Decision Date 06/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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