LOW PROFILE CROSSLINK® System

GUDID 00763000873578

22X10 CROSSLINK 6.35 TI STER

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system connector

• Primary Device ID: 00763000873578
• NIH Device Record Key: 3888b817-1940-42a0-a2e7-1021ebc5f812
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOW PROFILE CROSSLINK® System
• Version Model Number: G8116422
• 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: true
• 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
• 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	00763000873578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031888

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00763000873578]

Moist Heat or Steam Sterilization

[00763000873578]

Moist Heat or Steam Sterilization

[00763000873578]

Moist Heat or Steam Sterilization

[00763000873578]

Moist Heat or Steam Sterilization

[00763000873578]

Moist Heat or Steam Sterilization

[00763000873578]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-19
• Device Publish Date: 2025-05-10

On-Brand Devices [LOW PROFILE CROSSLINK® System]

• 00763000873585: 25X10 CROSSLINK 6.35 TI STER
• 00763000873578: 22X10 CROSSLINK 6.35 TI STER
• 00763000873561: 19X10 CROSSLINK 6.35 TI STER