MIDLINE (TM)

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 (tm).

Pre-market Notification Details

Device IDK133286
510k NumberK133286
Device Name:MIDLINE (TM)
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant CENTINEL SPINE, INC. 900 AIRPORT RD, STE #3B West Chester,  PA  19380
ContactJohn Parry
CorrespondentJohn Parry
CENTINEL SPINE, INC. 900 AIRPORT RD, STE #3B West Chester,  PA  19380
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-25
Decision Date2014-01-09
Summary:summary

NIH GUDID Devices

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