TEMPUS CERVICAL PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

NEUROSTRUCTURES, LLC

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

Pre-market Notification Details

Device IDK120515
510k NumberK120515
Device Name:TEMPUS CERVICAL PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant NEUROSTRUCTURES, LLC 4628 NORTHPARK DR Colorado Springs,  CO  80918
ContactMeredith May
CorrespondentMeredith May
NEUROSTRUCTURES, LLC 4628 NORTHPARK DR Colorado Springs,  CO  80918
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-21
Decision Date2012-05-23
Summary:summary

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