LT-CAGE® Lumbar Tapered Fusion Device

GUDID 00613994618733

CAGE X0509087 LT TAPERED THREAD 14X26

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 00613994618733
• NIH Device Record Key: e3bb24bc-298c-441a-ae96-1be7e9a79676
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LT-CAGE® Lumbar Tapered Fusion Device
• Version Model Number: X0509087
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994618733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970015

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00613994618733]

Moist Heat or Steam Sterilization

[00613994618733]

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: 2016-10-02

On-Brand Devices [LT-CAGE® Lumbar Tapered Fusion Device]

• 00613994618733: CAGE X0509087 LT TAPERED THREAD 14X26
• 00673978783802: CAGE 8941826 LT CAGE 18 X 22 X 26
• 00673978783796: CAGE 8941823 LT CAGE 18 X 21.5 X 23
• 00673978783789: CAGE 8941626 LT CAGE 16 X 20 X 26
• 00673978783772: CAGE 8941623 LT CAGE 16X19 5X23
• 00673978783765: CAGE 8941620 LT CAGE 16 X 19 X 20
• 00673978783758: CAGE 8941423 LT CAGE 14 X 17.5 X 23
• 00673978783741: CAGE 8941420 LT CAGE 14 X 17 X 20