The Micro Screw System, Micro Screw System Basic

Screw, Fixation, Intraosseous

Hager & Meisinger GmbH

The following data is part of a premarket notification filed by Hager & Meisinger Gmbh with the FDA for The Micro Screw System, Micro Screw System Basic.

Pre-market Notification Details

Device IDK201210
510k NumberK201210
Device Name:The Micro Screw System, Micro Screw System Basic
ClassificationScrew, Fixation, Intraosseous
Applicant Hager & Meisinger GmbH Hansemannstrasse 10 Neuss,  DE 41468
ContactSimon Göddeke
CorrespondentSimon Göddeke
Hager & Meisinger GmbH Hansemannstrasse 10 Neuss,  DE 41468
Product CodeDZL  
CFR Regulation Number872.4880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-05
Decision Date2021-10-08

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