OneLIF Intervertebral Body Replacement System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

NovApproach Spine

The following data is part of a premarket notification filed by Novapproach Spine with the FDA for Onelif Intervertebral Body Replacement System.

Pre-market Notification Details

Device IDK211769
510k NumberK211769
Device Name:OneLIF Intervertebral Body Replacement System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant NovApproach Spine 13900 Tech City Circle, Suite 300 Alachua,  FL  32615
ContactRonald P. Green
CorrespondentMeredith Lee May
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-08
Decision Date2021-09-07
Summary:summary

NIH GUDID Devices

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