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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 K191318
Device Name AEQUALIS FLEX REVIVE Shoulder System
Applicant
Tornier, Inc.
10801 Nesbitt Avenue South
Bloomington,  MN  55340
Applicant Contact Katie Molland
Correspondent
Tornier, Inc.
10801 Nesbitt Avenue South
Bloomington,  MN  55340
Correspondent Contact Katie Molland
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   PHX  
Date Received05/15/2019
Decision Date 06/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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