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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 K113413
Device Name ASCEND SHOULDER SYSTEM
Applicant
Tornier, Inc.
7701 France Ave. S.
Suite 600
Edina,  MN  55435
Applicant Contact BRAHIM HADRI
Correspondent
Tornier, Inc.
7701 France Ave. S.
Suite 600
Edina,  MN  55435
Correspondent Contact BRAHIM HADRI
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   KWT  
Date Received11/18/2011
Decision Date 03/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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