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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, non-constrained, metal/polymer cemented
510(k) Number K190521
Device Name Aequalis Ascend Flex Shoulder System
Applicant
Tornier SAS
161 Rue Lavoisier
monbonnot saint martin,  FR 38330
Applicant Contact lamia askri
Correspondent
Tornier SAS
161 Rue Lavoisier
monbonnot saint martin,  FR 38330
Correspondent Contact lamia askri
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Codes
HSD   KWS  
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
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