Velofix SA Cervical Cage

Intervertebral Fusion Device With Integrated Fixation, Cervical

U&I Corporation

The following data is part of a premarket notification filed by U&i Corporation with the FDA for Velofix Sa Cervical Cage.

Pre-market Notification Details

Device IDK210573
510k NumberK210573
Device Name:Velofix SA Cervical Cage
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant U&I Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si,  KR 11781
ContactJee-ae Bang
CorrespondentYoung-eun Lee
U&I Corporation 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si,  KR 11781
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-26
Decision Date2021-11-19

NIH GUDID Devices

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