Ti3Z Cervical Interbody System

Intervertebral Fusion Device With Bone Graft, Cervical

Zavation Medical Products, LLC

The following data is part of a premarket notification filed by Zavation Medical Products, Llc with the FDA for Ti3z Cervical Interbody System.

Pre-market Notification Details

Device IDK202398
510k NumberK202398
Device Name:Ti3Z Cervical Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Zavation Medical Products, LLC 220 Lakeland Parkway Flowood,  MS  39232
ContactKatie Motley
CorrespondentKatie Motley
Zavation Medical Products, LLC 220 Lakeland Parkway Flowood,  MS  39232
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-21
Decision Date2021-01-29

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