MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT

Screw, Fixation, Intraosseous

HAGER & MEISINGER GMBH

The following data is part of a premarket notification filed by Hager & Meisinger Gmbh with the FDA for Meisinger Tacs (meisinger Meitac-kit), Meisinger Pins (meisinger Master-pin-control-kit, Basic-kit.

Pre-market Notification Details

Device IDK130682
510k NumberK130682
Device Name:MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT
ClassificationScrew, Fixation, Intraosseous
Applicant HAGER & MEISINGER GMBH HANSEMANNSTRASSE 10 Neuss,  DE D-41468
ContactWiebke Stolten
CorrespondentWiebke Stolten
HAGER & MEISINGER GMBH HANSEMANNSTRASSE 10 Neuss,  DE D-41468
Product CodeDZL  
CFR Regulation Number872.4880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-13
Decision Date2013-08-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E0HM79MT0019 K130682 000
E0HM79BMPBA1 K130682 000
E0HM79BMP001 K130682 000
E0HM36MTAB09 K130682 000
E0HM36BMP0000101 K130682 000
E0HM36BMP000100101 K130682 000
E0HM36BMP000050101 K130682 000
E0HM79BMPPL1 K130682 000

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