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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 K051871
Device Name STOMA BONE SCREW
Applicant
Storz AM Mark GmbH
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Applicant Contact FRANZ MENEAN
Correspondent
Storz AM Mark GmbH
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Correspondent Contact FRANZ MENEAN
Regulation Number872.4880
Classification Product Code
DZL  
Date Received07/11/2005
Decision Date 10/27/2005
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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