Cervical Stand-Alone System

Intervertebral Fusion Device With Integrated Fixation, Cervical

Eminent Spine, LLC

The following data is part of a premarket notification filed by Eminent Spine, Llc with the FDA for Cervical Stand-alone System.

Pre-market Notification Details

Device IDK212853
510k NumberK212853
Device Name:Cervical Stand-Alone System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant Eminent Spine, LLC 2004 Ventura Drive, Suite 100 Plano,  TX  75093
ContactStephen Courtney
CorrespondentMeredith Lee May
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-07
Decision Date2021-11-05

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