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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K232251
Device Name APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension
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 Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTY  
Date Received07/28/2023
Decision Date 11/03/2023
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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