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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 K190521
Device Name Aequalis Ascend Flex Shoulder System
Applicant
Tornier S.A.S.
161 Rue Lavoisier
Monbonnot Saint Martin,  FR 38330
Applicant Contact Lamia Askri
Correspondent
Tornier S.A.S.
161 Rue Lavoisier
Monbonnot Saint Martin,  FR 38330
Correspondent Contact Lamia Askri
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   KWT   PHX  
Date Received03/04/2019
Decision Date 06/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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