BonOs HV, BonOs MV, BonOs LV

Bone Cement

Osartis GmbH

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

Pre-market Notification Details

Device IDK210120
510k NumberK210120
Device Name:BonOs HV, BonOs MV, BonOs LV
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 ProductNo
Date Received2021-01-19
Decision Date2021-03-19

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