UniVy OsteoVy Cervical IBF System

Intervertebral Fusion Device With Bone Graft, Cervical

Vy Spine, LLC

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

Pre-market Notification Details

Device IDK221162
510k NumberK221162
Device Name:UniVy OsteoVy Cervical IBF System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee,  FL  32308
ContactJordan Hendrickson
CorrespondentJordon Hendrickson
Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee,  FL  32308
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-22
Decision Date2022-11-04

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