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 IDK140449
510k NumberK140449
Device Name:CD HORIZON SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactGregory Maschek
CorrespondentGregory Maschek
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 CodeOSH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-24
Decision Date2014-03-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169377585 K140449 000
00643169377424 K140449 000
00643169377431 K140449 000
00643169377448 K140449 000
00643169377455 K140449 000
00643169377462 K140449 000
00643169377479 K140449 000
00643169377486 K140449 000
00643169377493 K140449 000
00643169377509 K140449 000
00643169377516 K140449 000
00643169377523 K140449 000
00643169377530 K140449 000
00643169377547 K140449 000
00643169377554 K140449 000
00643169377561 K140449 000
00643169377578 K140449 000
00643169377417 K140449 000

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