Zavation EZspand Interbody System

Intervertebral Fusion Device With Bone Graft, Lumbar

Zavation Medical Products, LLC

The following data is part of a premarket notification filed by Zavation Medical Products, Llc with the FDA for Zavation Ezspand Interbody System.

Pre-market Notification Details

Device IDK220581
510k NumberK220581
Device Name:Zavation EZspand Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Zavation Medical Products, LLC 220 Lakeland Parkway Flowood,  MS  39232
ContactMatt Jones
CorrespondentMatt Jones
Zavation Medical Products, LLC 220 Lakeland Parkway Flowood,  MS  39232
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-01
Decision Date2022-06-02

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