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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, Intraosseous
510(k) Number K093464
Device Name RAPIDSORB PLUS SCREW SYSTEM
Applicant
Synthes (Usa)
1230 Wilson Dr.
West Chester,  PA  19380
Applicant Contact SUSAN LEWANDOWSKI
Correspondent
Synthes (Usa)
1230 Wilson Dr.
West Chester,  PA  19380
Correspondent Contact SUSAN LEWANDOWSKI
Regulation Number872.4880
Classification Product Code
DZL  
Date Received11/06/2009
Decision Date 01/25/2010
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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