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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 K131231
Device Name AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
Applicant
Tornier S.A.S.
161 Rue Lavoisier
Montbonnot-Saint-Martin,  FR 38330
Applicant Contact SEVERINE BONNETON
Correspondent
Tornier S.A.S.
161 Rue Lavoisier
Montbonnot-Saint-Martin,  FR 38330
Correspondent Contact SEVERINE BONNETON
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWS  
Date Received04/30/2013
Decision Date 10/16/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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