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.

• 00613994927873 - CD HORIZON® Spinal System: 2024-08-16 SCR X1010574 5.5 RED MAS TI OGTHN 9.0X65
• 00763000864866 - T2 STRATOSPHERE™ Expandable Corpectomy System: 2024-08-13 INSERTER 4360113 13MM INSERTER
• 20763000607566 - CD Horizon™ ModuLeX™ Spinal System: 2024-08-13 RMAS/SS ST 559200021 ST 4.75/5.0 RMAS/SS
• 00763000607579 - CD Horizon™ ModuLeX™ Spinal System: 2024-08-13 RMAS/SS PK 559200022 STER 4.75/5.0 2PK
• 20763000607580 - CD Horizon™ ModuLeX™ Spinal System: 2024-08-13 RUAS/SS ST 559200023 ST 4.75/5.0 RUAS/SS
• 00763000607593 - CD Horizon™ ModuLeX™ Spinal System: 2024-08-13 RUAS/SS PK 559200024 STER 4.75/5.0 2PK
• 20763000607603 - CD Horizon™ ModuLeX™ Spinal System: 2024-08-13 RMASP/SSST 559200025 S 4.75/5.0 RMASP/SS
• 20763000607610 - CD Horizon™ ModuLeX™ Spinal System: 2024-08-13 RUASP/SSST 559200026 S 4.75/5.0 RUASP/SS