AFFIX II 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 Ii Spinous Process Plate System.

Pre-market Notification Details

Device IDK132411
510k NumberK132411
Device Name:AFFIX II 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 Received2013-08-02
Decision Date2013-11-20
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.