NuVasive CoRoent Small Ti-C System

Intervertebral Fusion Device With Bone Graft, Cervical

NUVASIVE, INCORPORATED

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

Pre-market Notification Details

Device IDK162138
510k NumberK162138
Device Name:NuVasive CoRoent Small Ti-C System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego,  CA  92121
ContactMichelle Cheung
CorrespondentMichelle Cheung
NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego,  CA  92121
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-01
Decision Date2016-10-26
Summary:summary

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