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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 K150583
Device Name Aequalis PerFORM+ Shoulder System
Applicant
Tornier, Inc.
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Applicant Contact Kris Miller
Correspondent
Tornier, Inc.
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Correspondent Contact Kris Miller
Regulation Number888.3660
Classification Product Code
KWS  
Date Received03/09/2015
Decision Date 04/23/2015
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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