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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 K201210
Device Name The Micro Screw System, Micro Screw System Basic
Applicant
Hager & Meisinger GmbH
Hansemannstrasse 10
Neuss,  DE 41468
Applicant Contact Simon Göddeke
Correspondent
Hager & Meisinger GmbH
Hansemannstrasse 10
Neuss,  DE 41468
Correspondent Contact Simon Göddeke
Regulation Number872.4880
Classification Product Code
DZL  
Date Received05/05/2020
Decision Date 10/08/2021
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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