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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