MSB CD HORIZON Spinal System

GUDID 00763000992019

ROD X0415065 DUAL BEND 6.0 TI S 350MM

MEDTRONIC SOFAMOR DANEK, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00763000992019
• NIH Device Record Key: c65b913b-c34c-425d-aa5a-cb01981e92df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MSB CD HORIZON Spinal System
• Version Model Number: X0415065
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000992019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113174

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00763000992019]

Moist Heat or Steam Sterilization

[00763000992019]

Moist Heat or Steam Sterilization

[00763000992019]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-23
• Device Publish Date: 2026-03-14

On-Brand Devices [MSB CD HORIZON Spinal System]

• 00763000992033: ROD X0415067 DUAL BEND 6.0 TI XL 490MM
• 00763000992019: ROD X0415065 DUAL BEND 6.0 TI S 350MM