VERTEX RCCONSTRUCTION SYSTEM

Appliance, Fixation, Spinal Interlaminal

MEDTRONIC SOFAMOR DANEK, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Vertex Rcconstruction System.

Pre-market Notification Details

Device IDK121191
510k NumberK121191
Device Name:VERTEX RCCONSTRUCTION SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactClaire Evans
CorrespondentClaire Evans
MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-19
Decision Date2012-06-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994531803 K121191 000
00613994531797 K121191 000
00613994531780 K121191 000
00613994531773 K121191 000
00613994531766 K121191 000
00613994531759 K121191 000

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