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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K050934
Device Name MODUS 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 Number872.4760
Classification Product Code
JEY  
Date Received04/14/2005
Decision Date 05/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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