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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 K141232
Device Name APTUS ULNA SHORTENING 2.5
Applicant
MEDARTIS AG
12264 EL CAMINO REAL, STE 400
san diego,  CA  92130
Applicant Contact kevin a thomas
Correspondent
MEDARTIS AG
12264 EL CAMINO REAL, STE 400
san diego,  CA  92130
Correspondent Contact kevin a thomas
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/13/2014
Decision Date 06/23/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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