Winch Kyphoplasty(15 And 20 Mm) 11 Gauge Balloon Catheters

Cement, Bone, Vertebroplasty

G21 S.r.l.

The following data is part of a premarket notification filed by G21 S.r.l. with the FDA for Winch Kyphoplasty(15 And 20 Mm) 11 Gauge Balloon Catheters.

Pre-market Notification Details

Device IDK152557
510k NumberK152557
Device Name:Winch Kyphoplasty(15 And 20 Mm) 11 Gauge Balloon Catheters
ClassificationCement, Bone, Vertebroplasty
Applicant G21 S.r.l. Via S. Pertini, 8 San Possidonio,  IT 41039
ContactMaurizio Foroni
CorrespondentBarry E Sands
RQMIS Inc. 29 Water Street, Suite 305 Newburyport,  MA  01950
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-08
Decision Date2016-02-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08058964726407 K152557 000
08058964726339 K152557 000

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