ARTiC-L™ Spinal System

GUDID 00763000085384

TRIAL 5251400 L 25 HT 14 DEG 0 FIXED

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00763000085384
• NIH Device Record Key: 60639bdf-4fd6-4156-992c-0908775d140f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTiC-L™ Spinal System
• Version Model Number: 5251400
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000085384 [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

[00763000085384]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-15
• Device Publish Date: 2019-03-07

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

• 00763000085391: TRIAL 5251500 L 25 HT 15 DEG 0 FIXED
• 00763000085384: TRIAL 5251400 L 25 HT 14 DEG 0 FIXED
• 00763000085339: TRIAL 5250900 L 25 HT 9 DEG 0 FIXED
• 00763000085414: TRIAL 5350800 L 35 HT 8 DEG 0 FIXED
• 00763000085407: TRIAL 5300800 L 30 HT 8 DEG 0 FIXED
• 00763000085322: TRIAL 5250800 L 25 HT 8 DEG 0 FIXED
• 00763000085353: TRIAL 5251100 L 25 HT 11 DEG 0 FIXED
• 00763000085346: TRIAL 5251000 L 25 HT 10 DEG 0 FIXED