G3 40 Radiopaque Bone Cement

Bone Cement

G21 S.r.l

The following data is part of a premarket notification filed by G21 S.r.l with the FDA for G3 40 Radiopaque Bone Cement.

Pre-market Notification Details

Device IDK193061
510k NumberK193061
Device Name:G3 40 Radiopaque Bone Cement
ClassificationBone Cement
Applicant G21 S.r.l Via S. Pertini, 8 San Possidonio,  IT 41039
ContactFlilippo Foroni
CorrespondentBarry E Sands
RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury,  MA  01913
Product CodeLOD  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-01
Decision Date2020-03-19

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