NUVASIVE SPHERX SYSTEM

Thoracolumbosacral Pedicle Screw System

NUVASIVE, INC.

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

Pre-market Notification Details

Device IDK082332
510k NumberK082332
Device Name:NUVASIVE SPHERX SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant NUVASIVE, INC. 7475 LUSK BLVD San Diego,  CA  92121
ContactLaetitia Cousin
CorrespondentLaetitia Cousin
NUVASIVE, INC. 7475 LUSK BLVD San Diego,  CA  92121
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-14
Decision Date2008-10-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887517111098 K082332 000

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