ARTiC-XL™ Spinal System

GUDID 00643169838048

TRIAL 54401525 L 40 HT 15 DEG 25

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00643169838048
• NIH Device Record Key: fbae52ba-0d35-442e-a074-dc67b1fa99a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTiC-XL™ Spinal System
• Version Model Number: 54401525
• 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: false
• 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	00643169838048 [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: true
• Device Is Sterile: false

[00643169838048]

Moist Heat or Steam Sterilization

[00643169838048]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-10-27

On-Brand Devices [ARTiC-XL™ Spinal System]

• 00643169838123: TRIAL 54501835 L 50 HT 18 DEG 35
• 00643169838116: TRIAL 54501535 L 50 HT 15 DEG 35
• 00643169838109: TRIAL 54501825 L 50 HT 18 DEG 25
• 00643169838093: TRIAL 54501525 L 50 HT 15 DEG 25
• 00643169838086: TRIAL 54501225 L 50 HT 12 DEG 25
• 00643169838079: TRIAL 54401835 L 40 HT 18 DEG 35
• 00643169838062: TRIAL 54401535 L 40 HT 15 DEG 35
• 00643169838055: TRIAL 54401825 L 40 HT 18 DEG 25
• 00643169838048: TRIAL 54401525 L 40 HT 15 DEG 25
• 00643169838031: TRIAL 54401225 L 40 HT 12 DEG 25
• 00643169838024: TRIAL 54301835 L 30 HT 18 DEG 35
• 00643169838000: TRIAL 54301825 L 30 HT 18 DEG 25
• 00643169837997: TRIAL 54301525 L 30 HT 15 DEG 25
• 00643169837980: TRIAL 54301225 L 30 HT 12 DEG 25
• 00643169838017: TRIAL 54301535 L 30 HT 15 DEG 35