MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM

Appliance, Fixation, Spinal Interlaminal

MEDTRONIC SOFAMOR DANEK

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modification To Vertex Reconstruction System.

Pre-market Notification Details

Device IDK071942
510k NumberK071942
Device Name:MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactMichelle Willis
CorrespondentMichelle Willis
MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-13
Decision Date2007-12-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994514493 K071942 000
00613994237637 K071942 000
00613994237675 K071942 000
00613994237682 K071942 000
00613994237699 K071942 000
00613994237705 K071942 000
00613994237712 K071942 000
00613994237729 K071942 000
00613994237736 K071942 000
00613994237873 K071942 000
00613994237880 K071942 000
00613994237897 K071942 000
00613994237903 K071942 000
00613994237910 K071942 000
00613994244451 K071942 000
00613994244468 K071942 000
00613994302823 K071942 000
00613994237620 K071942 000

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