Normandy VBR System

Spinal Vertebral Body Replacement Device - Cervical

Zavation Medical Products LLC

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

Pre-market Notification Details

Device IDK191423
510k NumberK191423
Device Name:Normandy VBR System
ClassificationSpinal Vertebral Body Replacement Device - Cervical
Applicant Zavation Medical Products LLC 220 Lakeland Parkway Flowood,  MS  39232
ContactFrankie Cummins
CorrespondentFrankie Cummins
Zavation Medical Products LLC 220 Lakeland Parkway Flowood,  MS  39232
Product CodePLR  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-29
Decision Date2019-08-06

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