V-STRUT Vertebral Implant

Cement, Bone, Vertebroplasty

Hyprevention SAS

The following data is part of a premarket notification filed by Hyprevention Sas with the FDA for V-strut Vertebral Implant.

Pre-market Notification Details

Device IDK191709
510k NumberK191709
Device Name:V-STRUT Vertebral Implant
ClassificationCement, Bone, Vertebroplasty
Applicant Hyprevention SAS PTIB - Hopital Xavier Arnozan - Avenue Du Haut-Leveque Pessac Cedex,  FR 33604
ContactCecile Vienney
CorrespondentCecile Vienney
Hyprevention SAS PTIB - Hopital Xavier Arnozan - Avenue Du Haut-Leveque Pessac Cedex,  FR 33604
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-26
Decision Date2020-03-05

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