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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 K103007
Device Name AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM
Applicant
Tornier, Inc.
100 Cummings Center,
Suite 444c
Beverly,  MA  01915
Applicant Contact BRAHIM HADRI
Correspondent
Tornier, Inc.
100 Cummings Center,
Suite 444c
Beverly,  MA  01915
Correspondent Contact BRAHIM HADRI
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received10/12/2010
Decision Date 11/09/2010
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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