NUVASIVE ACP4 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 Acp4 System.

Pre-market Notification Details

Device IDK062590
510k NumberK062590
Device Name:NUVASIVE ACP4 SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego,  CA  92121
ContactLaetitia Cousin
CorrespondentLaetitia Cousin
NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego,  CA  92121
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-01
Decision Date2007-01-18
Summary:summary

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