MONDRIAN ALIF Cage With Supplementary Fixation Plate

Intervertebral Fusion Device With Bone Graft, Lumbar

CTL Medical Corporation

The following data is part of a premarket notification filed by Ctl Medical Corporation with the FDA for Mondrian Alif Cage With Supplementary Fixation Plate.

Pre-market Notification Details

Device IDK213641
510k NumberK213641
Device Name:MONDRIAN ALIF Cage With Supplementary Fixation Plate
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant CTL Medical Corporation 4550 Excel Pkwy Ste 300 Addison,  TX  75001
ContactSean Suh
CorrespondentDhaval Saraiya
Omni Strategic Solutions, LLC 700 Pennsylvania Ave SE 2nd Floor Washington,  DC  20003
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-18
Decision Date2022-09-15

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