NuVasive CoRoent Small Interbody 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 Interbody System.

Pre-market Notification Details

Device IDK150362
510k NumberK150362
Device Name:NuVasive CoRoent Small Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant NuVasive, Incorporated 7475 Lusk Blvd. San Diego,  CA  92121
ContactMartin Yahiro
CorrespondentMartin Yahiro
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 Received2015-02-12
Decision Date2015-06-11
Summary:summary

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