NuVasive CoRoent Small Interlock System

Intervertebral Fusion Device With Integrated Fixation, Cervical

NuVasive, Incorporated

The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Coroent Small Interlock System.

Pre-market Notification Details

Device IDK192582
501k NumberK192582
Device Name:NuVasive CoRoent Small Interlock System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant NuVasive, Incorporated 7475 Lusk Blvd. San Diego,  CA  92121
ContactJessica Leblanc
CorrespondentJessica Leblanc
NuVasive, Incorporated 7475 Lusk Blvd. San Diego,  CA  92121
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-19
Decision Date2019-11-13

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