Vy Spine™ VyWasher™ Buttress System

Appliance, Fixation, Spinal Intervertebral Body

Vy Spine, LLC

The following data is part of a premarket notification filed by Vy Spine, Llc with the FDA for Vy Spine™ Vywasher™ Buttress System.

Pre-market Notification Details

Device IDK213219
510k NumberK213219
Device Name:Vy Spine™ VyWasher™ Buttress System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
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 CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-29
Decision Date2021-12-23

Trademark Results [Vy Spine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VY SPINE
VY SPINE
90864368 not registered Live/Pending
Vy Spine LLC
2021-08-04

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