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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 K193639
Device Name APTUS® Foot 2.8-3.5 System
Applicant
Medartis AG
Hochbergerstrasse 60e
Basel-Stadt,  CH CH-4057
Applicant Contact Andrea Kiefer-Schweizer
Correspondent
PaxMed International, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A Thomas
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   PLF  
Date Received12/27/2019
Decision Date 03/26/2020
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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