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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 K051567
Device Name APTUS TITANIUM OSTEOSYNTHESIS SYSTEM
Applicant
Medartis, Inc.
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Applicant Contact FLOYD G LARSON
Correspondent
Medartis, Inc.
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Correspondent Contact FLOYD G LARSON
Regulation Number888.3030
Classification Product Code
HRS  
Date Received06/14/2005
Decision Date 08/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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