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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 K142906
Device Name APTUS Wrist 2.5 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  
Subsequent Product Code
HWC  
Date Received10/06/2014
Decision Date 06/09/2015
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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