ELEVATE Spinal System

Intervertebral Fusion Device With Bone Graft, Lumbar

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 Elevate Spinal System.

Pre-market Notification Details

Device IDK142559
510k NumberK142559
Device Name:ELEVATE Spinal System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis,  TN  38132
ContactBecky Ronner
CorrespondentBecky Ronner
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis,  TN  38132
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-11
Decision Date2015-06-09
Summary:summary

NIH GUDID Devices

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