BASIS SPINAL SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

MEDTRONIC SOFAMOR DANEK USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Basis Spinal System.

Pre-market Notification Details

Device IDK051039
510k NumberK051039
Device Name:BASIS SPINAL SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard Treharne
CorrespondentRichard Treharne
MEDTRONIC 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 Received2005-04-25
Decision Date2005-05-12
Summary:summary

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