TITANIUM TSRH® Spinal System

GUDID 00673978132877

TSR 8.0X80 PROX VAS TI

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00673978132877
NIH Device Record Keyec1397ec-a60b-429b-98f4-acad3b8ec6ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameTITANIUM TSRH® Spinal System
Version Model NumberX0297-880
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length80 Millimeter
Length80 Millimeter
Length80 Millimeter
Length80 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100673978132877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00673978132877]

Moist Heat or Steam Sterilization


[00673978132877]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-24

On-Brand Devices [TITANIUM TSRH® Spinal System]

00673978144948TSR VAS-TI-9.5X50
00673978144931TSR VAS-TI-9.5X45
00673978144924TSR VAS-TI-9.5X40
00673978144917TSR VAS-TI-9.0X55
00673978137209TSR 6.5 VAS SPACER 6MM TI
00673978137193TSR 6.5 X0494-009 VAS SPACER 3MM TI
00673978137186TSR 5.5 VAS SPACER 6MM TI
00673978137179TSR 5.5 VAS SPACER 3MM TI
00673978132877TSR 8.0X80 PROX VAS TI
00673978132860TSR 7.0X70 PROX VAS TI

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