AFFIX SPINOUS PROCESS PLATE SYSTEM

Spinous Process Plate

NUVASIVE, INC.

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

Pre-market Notification Details

Device IDK131238
510k NumberK131238
Device Name:AFFIX SPINOUS PROCESS PLATE SYSTEM
ClassificationSpinous Process Plate
Applicant NUVASIVE, INC. 7475 LUSK BLVD San Diego,  CA  92121
ContactSheila Bruschi
CorrespondentSheila Bruschi
NUVASIVE, INC. 7475 LUSK BLVD San Diego,  CA  92121
Product CodePEK  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-01
Decision Date2013-07-02
Summary:summary

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