VERTEX RECONSTRUCTION SYSTEM

Appliance, Fixation, Spinal Interlaminal

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 Vertex Reconstruction System.

Pre-market Notification Details

Device IDK123568
510k NumberK123568
Device Name:VERTEX RECONSTRUCTION SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactMike Scott
CorrespondentMike Scott
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-20
Decision Date2012-12-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169108707 K123568 000
00643169108691 K123568 000
00643169108684 K123568 000
00643169108677 K123568 000
00643169108660 K123568 000
00643169108653 K123568 000
00643169108646 K123568 000
00643169108639 K123568 000

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