NUVASIVE HELIX REVOLUTION 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 Revolution Acp System.

Pre-market Notification Details

Device IDK093804
510k NumberK093804
Device Name:NUVASIVE HELIX REVOLUTION ACP 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 Received2009-12-11
Decision Date2010-02-19
Summary:summary

NIH GUDID Devices

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