G1 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 G1 40 Radiopaque Bone Cement.

Pre-market Notification Details

Device IDK193059
510k NumberK193059
Device Name:G1 40 Radiopaque Bone Cement
ClassificationBone Cement
Applicant G21 S.r.l. Via S. Pertini, 8 San Possidonio,  IT 41039
ContactFilippo 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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