NUVASIVE TRIAD FACET SCREW SYSTEM

System, Facet Screw Spinal Device

NUVASIVE, INC.

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

Pre-market Notification Details

Device IDK020411
510k NumberK020411
Device Name:NUVASIVE TRIAD FACET SCREW SYSTEM
ClassificationSystem, Facet Screw Spinal Device
Applicant NUVASIVE, INC. 10065 OLD GROVE RD. San Diego,  CA  92131
ContactLaetitia Bernard
CorrespondentLaetitia Bernard
NUVASIVE, INC. 10065 OLD GROVE RD. San Diego,  CA  92131
Product CodeMRW  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-07
Decision Date2002-03-12
Summary:summary

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