NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System

Spinal Vertebral Body Replacement Device

NuVasive Incorporated

The following data is part of a premarket notification filed by Nuvasive Incorporated with the FDA for Nuvasive X-core Expandable Vbr System, Nuvasive X-core Mini Cervical Expandable Vbr System.

Pre-market Notification Details

Device IDK193506
510k NumberK193506
Device Name:NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System
ClassificationSpinal Vertebral Body Replacement Device
Applicant NuVasive Incorporated 7475 Lusk Boulevard San Diego,  CA  92121
ContactAditya Sharma
CorrespondentAditya Sharma
NuVasive Incorporated 7475 Lusk Boulevard San Diego,  CA  92121
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-18
Decision Date2020-02-26

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