DUAL ROD ANTERIOR FIXATOR SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

SOFAMOR DANEK USA,INC.

The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Dual Rod Anterior Fixator System.

Pre-market Notification Details

Device IDK963780
510k NumberK963780
Device Name:DUAL ROD ANTERIOR FIXATOR SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard W Treharne
CorrespondentRichard W Treharne
SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-20
Decision Date1997-07-30
Summary:summary

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