LumiVy Lumbar IBF System

Intervertebral Fusion Device With Bone Graft, Lumbar

Vy Spine, LLC

The following data is part of a premarket notification filed by Vy Spine, Llc with the FDA for Lumivy Lumbar Ibf System.

Pre-market Notification Details

Device IDK212930
510k NumberK212930
Device Name:LumiVy Lumbar IBF System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee,  FL  32308
ContactJordan Hendrickson
CorrespondentJordan Hendrickson
Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee,  FL  32308
Product CodeMAX  
Subsequent Product CodeMQP
Subsequent Product CodeODP
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-14
Decision Date2022-02-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.