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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 K141345
Device Name AEQUALIS FX2
Applicant
Tornier SAS
161 RUE LAVOISIER
MONTBONNOT SAINT MARTIN,  FR 38330
Applicant Contact MAUD ANDRIOLLO
Correspondent
Tornier SAS
161 RUE LAVOISIER
MONTBONNOT SAINT MARTIN,  FR 38330
Correspondent Contact MAUD ANDRIOLLO
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWS  
Date Received05/22/2014
Decision Date 11/18/2014
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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