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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 K071612
Device Name MODUS TRILOCK 2.0/2.3/2.5
Applicant
MEDARTIS AG
11234 EL CAMINO REAL, STE 200
SAN DIEGO,  CA  92130
Applicant Contact LINDA SCHULZ
Correspondent
MEDARTIS AG
11234 EL CAMINO REAL, STE 200
SAN DIEGO,  CA  92130
Correspondent Contact LINDA SCHULZ
Regulation Number872.4760
Classification Product Code
JEY  
Date Received06/13/2007
Decision Date 09/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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