NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

NUVASIVE, INC.

The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Anterior Lumbar Plate System.

Pre-market Notification Details

Device IDK111866
510k NumberK111866
Device Name:NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant NUVASIVE, INC. 7475 LUSK BLVD San Diego,  CA  92121
ContactSheila Bruschi
CorrespondentSheila Bruschi
NUVASIVE, INC. 7475 LUSK BLVD San Diego,  CA  92121
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-30
Decision Date2011-07-22
Summary:summary

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