TSRH SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

MEDTRONIC SOFAMOR DANCK USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danck Usa, Inc. with the FDA for Tsrh Spinal System.

Pre-market Notification Details

Device IDK110070
510k NumberK110070
Device Name:TSRH SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant MEDTRONIC SOFAMOR DANCK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactLila Joe
CorrespondentLila Joe
MEDTRONIC SOFAMOR DANCK USA, 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 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-10
Decision Date2011-06-08
Summary:summary

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