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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 K102537
Device Name APTUS 1.5 TRILOCK
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 Received09/03/2010
Decision Date 12/10/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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