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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Arthroplasty Implantation System
510(k) Number K243509
Device Name Archer PSI System
Applicant
3D-Side
Rue André Dumont 5
Mont-Saint-Guibert,  BE 1435
Applicant Contact Florence Allé
Correspondent
3D-Side
Rue André Dumont 5
Mont-Saint-Guibert,  BE 1435
Correspondent Contact Florence Allé
Regulation Number888.3660
Classification Product Code
QHE  
Subsequent Product Codes
KWS   PHX  
Date Received11/12/2024
Decision Date 05/12/2025
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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