NUVASIVE COROENT NO-PROFILE SYSTEM

Intervertebral Fusion Device With Integrated Fixation, Lumbar

NUVASIVE, INC.

The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Coroent No-profile System.

Pre-market Notification Details

Device IDK112561
510k NumberK112561
Device Name:NUVASIVE COROENT NO-PROFILE SYSTEM
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant NUVASIVE, INC. 7475 LUSK BLVD San Diego,  CA  92121
ContactSheila Bruschi
CorrespondentSheila Bruschi
NUVASIVE, INC. 7475 LUSK BLVD San Diego,  CA  92121
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-02
Decision Date2012-03-13
Summary:summary

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