EMINENT SPINE INTERBODY FUSION SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

EMINENT SPINE

The following data is part of a premarket notification filed by Eminent Spine with the FDA for Eminent Spine Interbody Fusion System.

Pre-market Notification Details

Device IDK090064
510k NumberK090064
Device Name:EMINENT SPINE INTERBODY FUSION SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant EMINENT SPINE 16001 RONALD REAGAN BLVD. Leander,  TX  78641
ContactDave Freehill
CorrespondentDave Freehill
EMINENT SPINE 16001 RONALD REAGAN BLVD. Leander,  TX  78641
Product CodeMAX  
Subsequent Product CodeMQP
Subsequent Product CodeODP
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-09
Decision Date2009-04-09
Summary:summary

NIH GUDID Devices

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