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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, shoulder, semi-constrained, metal/polymer cemented
510(k) Number K122698
Device Name AEQUALIS ASCEND FLEX SHOULDER SYSTEM
Original Applicant
TORNIER SAS
10801 nesbitt avenue south
bloomington,  MN  55437
Original Contact brahim hadri
Regulation Number888.3660
Classification Product Code
KWS  
Date Received09/04/2012
Decision Date 01/08/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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