SOVEREIGN SPINAL SYSTEM

Intervertebral Fusion Device With Integrated Fixation, Lumbar

MEDTRONIC SOFAMOR DANEK

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

Pre-market Notification Details

Device IDK121982
510k NumberK121982
Device Name:SOVEREIGN SPINAL SYSTEM
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactLauren Kamer
CorrespondentLauren Kamer
MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-06
Decision Date2012-07-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000191818 K121982 000

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