MIDLINE II TI

Intervertebral Fusion Device With Integrated Fixation, Lumbar

CENTINEL SPINE, INC.

The following data is part of a premarket notification filed by Centinel Spine, Inc. with the FDA for Midline Ii Ti.

Pre-market Notification Details

Device IDK141942
510k NumberK141942
Device Name:MIDLINE II TI
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant CENTINEL SPINE, INC. 1331 H. ST. NW, 12TH FLOOR Washington,  DC  20005
ContactJustin Eggleton
CorrespondentJustin Eggleton
CENTINEL SPINE, INC. 1331 H. ST. NW, 12TH FLOOR Washington,  DC  20005
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-17
Decision Date2014-11-07
Summary:summary

NIH GUDID Devices

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