NuVasive NuvaLine

System, Image Processing, Radiological

NuVasive, Incorporated

The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Nuvaline.

Pre-market Notification Details

Device IDK192435
510k NumberK192435
Device Name:NuVasive NuvaLine
ClassificationSystem, Image Processing, Radiological
Applicant NuVasive, Incorporated 7475 Lusk Boulevard San Diego,  CA  92121
ContactManthan Damani
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2019-09-05
Decision Date2019-09-26
Summary:summary

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