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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 K992682
Device Name MODUS 2.5 MANDIBULAR RECONSTRUCTION SET
Applicant
Medartis AG
1601 Trapelo Rd.
Reservoir Pl.
Waltham,  MA  02451
Applicant Contact LINDA JALBERT
Correspondent
Medartis AG
1601 Trapelo Rd.
Reservoir Pl.
Waltham,  MA  02451
Correspondent Contact LINDA JALBERT
Regulation Number872.4760
Classification Product Code
JEY  
Date Received08/10/1999
Decision Date 11/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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