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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 K193633
Device Name APTUS® Ankle Trauma System 2.8/3.5
Medartis AG
Hochbergerstrasse 60E
Basel,  CH CH-4057
Applicant Contact Andrea Kiefer-Schweizer
PaxMed International, LLC
12264 EL Camino Real. Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A. Thomas
Regulation Number888.3030
Classification Product Code
Subsequent Product Codes
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