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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 K120739
Device Name AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM
Original Applicant
TORNIER, INC.
7701 france ave south
suite 600
edina,  MN  55435
Original Contact brahim hadri
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   KWT  
Date Received03/12/2012
Decision Date 07/05/2012
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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