C-CURVE Interbody Fusion Device

Intervertebral Fusion Device With Integrated Fixation, Cervical

Medicrea International S. A.

The following data is part of a premarket notification filed by Medicrea International S. A. with the FDA for C-curve Interbody Fusion Device.

Pre-market Notification Details

Device IDK210470
510k NumberK210470
Device Name:C-CURVE Interbody Fusion Device
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant Medicrea International S. A. 5389 Route De Strasbourg - Vancia Rillieux-la-pape,  FR 69140
ContactKarine Trogneux
CorrespondentKarine Trogneux
Medicrea International S. A. 5389 Route De Strasbourg - Vancia Rillieux-la-pape,  FR 69140
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-17
Decision Date2021-09-03

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.