ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology

GUDID 00643169800595

SPACER 53501835 50MM X 18MM 35 DEGREE TI

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00643169800595
• NIH Device Record Key: 18a259d7-db2d-4eb6-b6bb-505078fef64e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology
• Version Model Number: 53501835
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00643169800595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171689

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-10-27

On-Brand Devices [ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology]

• 00643169844209: TRAY 5332030 TI INTERBODY INSTRUMENTS
• 00643169800595: SPACER 53501835 50MM X 18MM 35 DEGREE TI
• 00643169800588: SPACER 53501535 50MM X 15MM 35 DEGREE TI
• 00643169800571: SPACER 53501825 50MM X 18MM 25 DEGREE TI
• 00643169800564: SPACER 53501525 50MM X 15MM 25 DEGREE TI
• 00643169800557: SPACER 53501225 50MM X 12MM 25 DEGREE TI
• 00643169800540: SPACER 53401835 40MM X 18MM 35 DEGREE TI
• 00643169800533: SPACER 53401535 40MM X 15MM 35 DEGREE TI
• 00643169800526: SPACER 53401825 40MM X 18MM 25 DEGREE TI
• 00643169800519: SPACER 53401525 40MM X 15MM 25 DEGREE TI
• 00643169800502: SPACER 53401225 40MM X 12MM 25 DEGREE TI
• 00643169800496: SPACER 53301835 30MM X 18MM 35 DEGREE TI
• 00643169800489: SPACER 53301535 30MM X 15MM 35 DEGREE TI
• 00643169800472: SPACER 53301825 30MM X 18MM 25 DEGREE TI
• 00643169800465: SPACER 53301525 30MM X 15MM 25 DEGREE TI
• 00643169800458: SPACER 53301225 30MM X 12MM 25 DEGREE TI
• 00763000086305: TRAY 5332030 TI INTERBODY INSTRUMENTS