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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name staple, fixation, bone
510(k) Number K191636
Device Name APTUS Foot 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
JDR  
Subsequent Product Codes
HRS   HWC  
Date Received06/19/2019
Decision Date 08/16/2019
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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