Affix IIS Spinous Process Plate System

Spinous Process Plate

NuVasive, Incorporated

The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Affix Iis Spinous Process Plate System.

Pre-market Notification Details

Device IDK143388
510k NumberK143388
Device Name:Affix IIS Spinous Process Plate System
ClassificationSpinous Process Plate
Applicant NuVasive, Incorporated 7475 Lusk Boulevard San Diego,  CA  92121
ContactOlga Lewis
CorrespondentOlga Lewis
NuVasive, Incorporated 7475 Lusk Boulevard San Diego,  CA  92121
Product CodePEK  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-26
Decision Date2015-03-05
Summary:summary

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