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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shoulder prosthesis, reverse configuration
510(k) Number K161742
Device Name Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
Applicant
Tornier, Inc.
10801 Nesbitt Avenue South
Bloomington,  MN  55340
Applicant Contact Laurie Lewandowski
Correspondent
Tornier, Inc.
10801 Nesbitt Avenue South
Bloomington,  MN  55340
Correspondent Contact Laurie Lewandowski
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received06/24/2016
Decision Date 11/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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