Oculus-SA Lumbar Cage System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Neurostructures

The following data is part of a premarket notification filed by Neurostructures with the FDA for Oculus-sa Lumbar Cage System.

Pre-market Notification Details

Device IDK202190
510k NumberK202190
Device Name:Oculus-SA Lumbar Cage System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant Neurostructures 199 Technology Drive, Suite 110 Irvine,  CA  92618
ContactMoti Altarac
CorrespondentNathan Wright
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 Received2020-08-05
Decision Date2020-10-02

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