MSB|CD HORIZON® Spinal System

GUDID 00763000780623

SCREW 54740105545 4.75 HA MAS 5.5X45 CC

MEDTRONIC SOFAMOR DANEK, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00763000780623
• NIH Device Record Key: 1baf1371-ef13-42b1-9f2d-8aa6e4a47f19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MSB|CD HORIZON® Spinal System
• Version Model Number: 54740105545
• 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
• 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
• 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 Dimensions

• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000780623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112555

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-04
• Device Publish Date: 2025-01-27

On-Brand Devices [MSB|CD HORIZON® Spinal System]

• 00763000872298: SCREW 54740106545 4.75 HA MAS 6.5X45 CC
• 00763000872250: SCREW 54740107545 4.75 HA MAS 7.5X45 CC
• 00763000872243: SCREW 54740107550 4.75 HA MAS 7.5X50 CC
• 00763000780623: SCREW 54740105545 4.75 HA MAS 5.5X45 CC