COLORADO 2 SPINAL SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

MEDTRONIC SOFAMOR DANEK, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Colorado 2 Spinal System.

Pre-market Notification Details

Device IDK020247
510k NumberK020247
Device Name:COLORADO 2 SPINAL SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard Treharne
CorrespondentRichard Treharne
MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-24
Decision Date2002-07-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00673978057460 K020247 000

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