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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, STE 200
san diego,  CA  92130
Applicant Contact floyd g larson
Correspondent
MEDARTIS, INC.
11234 EL CAMINO REAL, STE 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
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