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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 K223853
Device Name Medartis APTUS® Ulna Plates
Applicant
Medartis AG
Hochbergerstrasse 60E
Basel,  CH CH-4057
Applicant Contact Claudia De Santis
Correspondent
Medartis AG
Hochbergerstrasse 60E
Basel,  CH CH-4057
Correspondent Contact Claudia De Santis
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/23/2022
Decision Date 03/30/2023
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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