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 IDK161442
510k NumberK161442
Device Name:NuVasive® CoRoent® Small Interlock™ System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant NUVASIVE INCORPORATED 7475 LUSK BOULEVARD San Diego,  CA  92121
ContactCynthia Adams
CorrespondentCynthia Adams
NUVASIVE INCORPORATED 7475 LUSK BOULEVARD San Diego,  CA  92121
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-25
Decision Date2016-09-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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Trademark Results [NuVasive]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NUVASIVE
NUVASIVE
76298757 2818737 Live/Registered
NUVASIVE, INC.
2001-08-10
NUVASIVE
NUVASIVE
75822001 2541247 Live/Registered
NUVASIVE, INC.
1999-10-13

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