NUVASIVE HELIX MINI ACP 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 Helix Mini Acp System.

Pre-market Notification Details

Device IDK073275
510k NumberK073275
Device Name:NUVASIVE HELIX MINI ACP 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 Received2007-11-21
Decision Date2008-01-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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