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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K992106
Device Name MODUS SYSTEM SELF-DRILLING SCREWS
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 Number888.3040
Classification Product Code
HWC  
Date Received06/22/1999
Decision Date 09/17/1999
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
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