INTREPID 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 Intrepid Spinal System.

Pre-market Notification Details

Device IDK091813
510k NumberK091813
Device Name:INTREPID SPINAL SYSTEM
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactMike Scott
CorrespondentMike Scott
MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-18
Decision Date2009-11-17
Summary:summary

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