ARTiC-L Spinal System

GUDID 00763000085360

TRIAL 5251200 L 25 HT 12 DEG 0 FIXED

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00763000085360
• NIH Device Record Key: 30e9f421-8865-45de-ba0d-9e46430a5674
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTiC-L Spinal System
• Version Model Number: 5251200
• 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
• 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	00763000085360 [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

[00763000085360]

Moist Heat or Steam Sterilization

[00763000085360]

Moist Heat or Steam Sterilization

[00763000085360]

Moist Heat or Steam Sterilization

[00763000085360]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-30
• Device Publish Date: 2022-05-20

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000681401 - CD HORIZON® Spinal System: 2025-07-18 75753019 INSTRUMENT MULTILVL OUTR EXTNDR
• 00763000681432 - CD HORIZON® Spinal System: 2025-07-18 INSTRUMENT 7576305 REDUCTION INNER SLEEV
• 00763000681449 - CD HORIZON® Spinal System: 2025-07-18 INSTRUMENT 7576301 REDCTN OUTR EXTNDR ML
• 00763000681456 - CD HORIZON® Spinal System: 2025-07-18 INSTRUMENT 7576302 REDCTN MDL EXTNDR ML
• 00763000681463 - CD HORIZON® Spinal System: 2025-07-18 INSTRUMENT 7576303 REDUCTION EXTNDR A SL
• 00763000684426 - CD HORIZON® Spinal System: 2025-07-18 ROD 7575300 INSERTER
• 00763000684433 - CD HORIZON® Spinal System: 2025-07-18 75753059 INSTRUMENT EXTNDER INNER SLEEVE
• 00763000684440 - CD HORIZON® Spinal System: 2025-07-18 75753029 INSTRUMENT MULTILEVL MID EXTNDR