ORION ANTERIOR CERVICAL PLATING SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

MEDTRONIC SOFAMOR DANEK

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Orion Anterior Cervical Plating System.

Pre-market Notification Details

Device IDK042235
510k NumberK042235
Device Name:ORION ANTERIOR CERVICAL PLATING SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard Treharne
CorrespondentRichard Treharne
MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-18
Decision Date2004-09-17
Summary:summary

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