COROENT SINGLE TAB SYSTEM

Intervertebral Fusion Device With Integrated Fixation, Lumbar

NUVASIVE, INC.

The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Coroent Single Tab System.

Pre-market Notification Details

Device IDK131723
510k NumberK131723
Device Name:COROENT SINGLE TAB SYSTEM
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant NUVASIVE, INC. 7475 LUSK BLVD San Diego,  CA  92121
ContactJeremy Markovich
CorrespondentJeremy Markovich
NUVASIVE, INC. 7475 LUSK BLVD San Diego,  CA  92121
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-12
Decision Date2013-09-20
Summary:summary

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