NUVASIVE SPHERX SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

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 IDK060225
510k NumberK060225
Device Name:NUVASIVE SPHERX SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
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 CodeMNH  
Subsequent Product CodeKWQ
Subsequent Product CodeNKB
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-30
Decision Date2006-04-12
Summary:summary

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