VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT 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, Vertext Select Reconstruction System.

Pre-market Notification Details

Device IDK123906
510k NumberK123906
Device Name:VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactClaire Evans
CorrespondentClaire Evans
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-19
Decision Date2013-04-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994932433 K123906 000
00643169098305 K123906 000
00643169096974 K123906 000

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