Transept Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Neurostructures, Inc.

The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Transept Cervical Plate System.

Pre-market Notification Details

Device IDK200927
510k NumberK200927
Device Name:Transept Cervical Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant Neurostructures, Inc. 199 Technology Dr. Suite 110 Irvine,  CA  92618
ContactMoti Altarac
CorrespondentNathan Wright
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-07
Decision Date2020-07-24

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