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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K253916
Device Name APTUS Shoulder Proximal Humerus System, PentaLock 3.5
Applicant
Medartis AG
Hochbergerstrasse 60e
Basel,  CH 4057
Applicant Contact Salvatore Risoli
Correspondent
Medartis AG
Hochbergerstrasse 60e
Basel,  CH 4057
Correspondent Contact Salvatore Risoli
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/08/2025
Decision Date 03/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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