CD HORIZON SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

MEDTRONIC SOFAMOR DANEK, INC.

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

Pre-market Notification Details

Device IDK111510
510k NumberK111510
Device Name:CD HORIZON SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactKevin Ford
CorrespondentKevin Ford
MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeNQP
Subsequent Product CodeOSH
CFR Regulation Number888.3070 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-01
Decision Date2011-09-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00613994929396 K111510 000
00613994929389 K111510 000
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00613994929464 K111510 000
00613994929457 K111510 000
00613994929440 K111510 000
00613994929433 K111510 000
00613994929310 K111510 000

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