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

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• 00763000670559 - n/a: 2024-11-18 TEMPLATE 3005977 ZEVO 77MM 5 LVL
• 00763000670566 - n/a: 2024-11-18 TEMPLATE 3005979 ZEVO 79MM 5 LVL
• 00763000670573 - n/a: 2024-11-18 TEMPLATE 3005981 ZEVO 81MM 5 LVL
• 00763000670580 - n/a: 2024-11-18 TEMPLATE 3005985 ZEVO 85MM 5 LVL
• 00763000670597 - n/a: 2024-11-18 TEMPLATE 3005990 ZEVO 90MM 5 LVL
• 00763000670603 - n/a: 2024-11-18 TEMPLATE 3005995 ZEVO 95MM 5 LVL