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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 K112169
Device Name APTUS WRIST ARTHRODESIS PLATES
Applicant
MEDARTIS AG
11234 EL CAMINO REAL,
SUITE 200
SAN DIEGO,  CA  92130
Applicant Contact KEVIN A THOMAS
Correspondent
MEDARTIS AG
11234 EL CAMINO REAL,
SUITE 200
SAN DIEGO,  CA  92130
Correspondent Contact KEVIN A THOMAS
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/28/2011
Decision Date 01/06/2012
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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