Intervertebral Fusion Device With Bone Graft, Lumbar

NGMedical GmbH

The following data is part of a premarket notification filed by Ngmedical Gmbh with the FDA for Bee Plif Cage.

Pre-market Notification Details

Device IDK211413
510k NumberK211413
Device Name:BEE PLIF Cage
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant NGMedical GmbH Talsperrenblick 5 Nonnweiler,  DE 66620
ContactStella Hahn
CorrespondentChristine Scifert
MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial,  CO  80112
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-06
Decision Date2021-08-27

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