G21 SpaceFlex Hip

Bone Cement, Antibiotic

G21 S.r.l

The following data is part of a premarket notification filed by G21 S.r.l with the FDA for G21 Spaceflex Hip.

Pre-market Notification Details

Device IDK192041
510k NumberK192041
Device Name:G21 SpaceFlex Hip
ClassificationBone Cement, Antibiotic
Applicant G21 S.r.l Via Sandro Petrini, 8 San Possidonio,  IT 41039
ContactFilippo Foroni
CorrespondentBarry Sands
RQMIS, Inc. 110 Haverhill Road, Suite #526 Amesbury,  MA  01860
Product CodeMBB  
Subsequent Product CodeKWL
Subsequent Product CodeKWY
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-31
Decision Date2019-10-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08058964726902 K192041 000
08058964726896 K192041 000
08058964726889 K192041 000
08058964726186 K192041 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.