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 Coroent Small Interlock System.

Pre-market Notification Details

Device IDK142299
510k NumberK142299
Device Name:CoRoent Small Interlock System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego,  CA  92121
ContactCynthia Adams
CorrespondentCynthia Adams
NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego,  CA  92121
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-18
Decision Date2014-11-25
Summary:summary

NIH GUDID Devices

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