CONFIRM BIOACTIVE

Filler, Bone Void, Calcium Compound

GLOBUS MEDICAL, INC.

The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Confirm Bioactive.

Pre-market Notification Details

Device IDK133678
510k NumberK133678
Device Name:CONFIRM BIOACTIVE
ClassificationFiller, Bone Void, Calcium Compound
Applicant GLOBUS MEDICAL, INC. 2560 General Armistead Ave VALLEY FORGE BUSINESS CENTER Audubon,  PA  19403
ContactChristina Kichula
CorrespondentKelly Baker
GLOBUS MEDICAL, INC. 2560 General Armistead Ave VALLEY FORGE BUSINESS CENTER Audubon,  PA  19403
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-29
Decision Date2014-08-26
Summary:summary

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