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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 K112560
Device Name APTUS(R) DISTAL HUMERUS SYSTEM
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  
Subsequent Product Code
HWC  
Date Received09/02/2011
Decision Date 12/15/2011
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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