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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
510(k) Number K143552
Device Name Simpliciti Shoulder System
Applicant
Tornier, Inc.
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Applicant Contact Loucinda Bjorklund
Correspondent
Tornier, Inc.
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Correspondent Contact Loucinda Bjorklund
Regulation Number888.3660
Classification Product Code
PKC  
Date Received12/15/2014
Decision Date 03/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT01390038
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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