TITANIUM TSRH® Spinal System

GUDID 00673978137209

TSR 6.5 VAS SPACER 6MM TI

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00673978137209
• NIH Device Record Key: 3bb4de15-5e01-47d6-96c8-8188f49ad7b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TITANIUM TSRH® Spinal System
• Version Model Number: X0494-010
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978137209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000991

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

[00673978137209]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-08-24

On-Brand Devices [TITANIUM TSRH® Spinal System]

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