SpaceFlex Shoulder

Bone Cement, Antibiotic

G21 Srl

The following data is part of a premarket notification filed by G21 Srl with the FDA for Spaceflex Shoulder.

Pre-market Notification Details

Device IDK202338
510k NumberK202338
Device Name:SpaceFlex Shoulder
ClassificationBone Cement, Antibiotic
Applicant G21 Srl Via Sandro Pertini, 8 San Possidonio,  IT 41039
ContactFilippo Foroni
CorrespondentBarry Sands
RQMIS, Inc. 110 Haverhill Road, Suite 524 Amesbury,  MA  01913
Product CodeMBB  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-17
Decision Date2021-02-17

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