NuVasive Foundation-LL System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

NUVASIVE INCORPORATED

The following data is part of a premarket notification filed by Nuvasive Incorporated with the FDA for Nuvasive Foundation-ll System.

Pre-market Notification Details

Device IDK152943
510k NumberK152943
Device Name:NuVasive Foundation-LL System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant NUVASIVE INCORPORATED 7475 LUSK BOULEVARD San Diego,  CA  92121
ContactCynthia Adams
CorrespondentCynthia Adams
NUVASIVE INCORPORATED 7475 LUSK BOULEVARD San Diego,  CA  92121
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-05
Decision Date2015-12-01
Summary:summary

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