BonOs HV Genta, BonOs MV Genta, BonOs LV Genta

Bone Cement

OSARTIS GmbH

The following data is part of a premarket notification filed by Osartis Gmbh with the FDA for Bonos Hv Genta, Bonos Mv Genta, Bonos Lv Genta.

Pre-market Notification Details

Device IDK210125
510k NumberK210125
Device Name:BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
ClassificationBone Cement
Applicant OSARTIS GmbH Auf Der Beune 101 Munster,  DE 64839
ContactVolker Stirnal
CorrespondentVolker Stirnal
OSARTIS GmbH Auf Der Beune 101 Munster,  DE 64839
Product CodeLOD  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-01-19
Decision Date2021-03-19

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