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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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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