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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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