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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 K152966
Device Name Aequalis Fx2
Applicant
Tornier S.A.S.
161 Rue Lavoisier
Montbonnot Saint Martin,  FR 38330
Applicant Contact JOVILA DODI
Correspondent
Tornier S.A.S.
161 Rue Lavoisier
Montbonnot Saint Martin,  FR 38330
Correspondent Contact JOVILA DODI
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWS  
Date Received10/07/2015
Decision Date 01/14/2016
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
Recalls CDRH Recalls
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