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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 K181009
Device Name APTUS CMC-I Fusion Plate System
Applicant
Medartis AG
Hochbergerstrasse 60E
Basel,  CH CH-4057
Applicant Contact Andrea 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  
Date Received04/17/2018
Decision Date 08/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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