SpaceFlex Knee - 80mm Size

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 Spaceflex Knee - 80mm Size.

Pre-market Notification Details

Device IDK201960
510k NumberK201960
Device Name:SpaceFlex Knee - 80mm Size
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  01913
Product CodeMBB  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-14
Decision Date2020-08-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08058964727039 K201960 000

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