PERIMETER INTERBODY FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

MEDTRONIC SOFAMOR DANEK USA

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa with the FDA for Perimeter Interbody Fusion Device.

Pre-market Notification Details

Device IDK113642
510k NumberK113642
Device Name:PERIMETER INTERBODY FUSION DEVICE
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant MEDTRONIC SOFAMOR DANEK USA 1800 PYRAMID PLACE Memphis,  TN  38132
ContactLauren Kamer
CorrespondentLauren Kamer
MEDTRONIC SOFAMOR DANEK USA 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-12
Decision Date2012-02-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994989956 K113642 000

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