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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E0HM79BMSPL1 K201210 000
E0HM39MSS100401 K201210 000
E0HM39MSS100601 K201210 000
E0HM39MSS100801 K201210 000
E0HM39MSS101001 K201210 000
E0HM39MSS101201 K201210 000
E0HM39MSS101401 K201210 000
E0HM39MSS120401 K201210 000
E0HM39MSS120601 K201210 000
E0HM39MSS120801 K201210 000
E0HM39MSS121001 K201210 000
E0HM39MSS121201 K201210 000
E0HM39MSS121401 K201210 000
E0HM79BMS001 K201210 000
E0HM79BMSBA1 K201210 000
E0HM79BMA021 K201210 000

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