CLYDESDALES 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 Clydesdales Spinal System.

Pre-market Notification Details

Device IDK112405
510k NumberK112405
Device Name:CLYDESDALES SPINAL SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactJulie Bassett
CorrespondentJulie Bassett
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 Received2011-08-22
Decision Date2011-11-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994866523 K112405 000

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