MONDRIAN Lumbar Interbody Fusion Cage System

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 Lumbar Interbody Fusion Cage System.

Pre-market Notification Details

Device IDK192863
510k NumberK192863
Device Name:MONDRIAN Lumbar Interbody Fusion Cage System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant CTL Medical Corporation 4550 Excel Parkway #300 Addison,  TX  75001
ContactSean Suh
CorrespondentBarry E Sands
RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury,  MA  01913
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-07
Decision Date2020-08-26

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.