CD Horizon™ Spinal System

GUDID 00763000360306

ROD 9010014632 6.0 TI 12MM OFFSET

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00763000360306
• NIH Device Record Key: 5b335cf6-b88b-42c2-a43d-c42b95831e4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD Horizon™ Spinal System
• Version Model Number: 9010014632
• 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
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000360306 [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

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

[00763000360306]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-04
• Device Publish Date: 2020-12-27

On-Brand Devices [CD Horizon™ Spinal System]

• 00763000360344: ROD 9010014636 6.0 TI 13.8MM OFFSET
• 00763000360337: ROD 9010014635 6.0 TI 13.5MM OFFSET
• 00763000360320: ROD 9010014634 6.0 TI 13.1MM OFFSET
• 00763000360313: ROD 9010014633 6.0 TI 12.8MM OFFSET
• 00763000360306: ROD 9010014632 6.0 TI 12MM OFFSET
• 00763000360290: ROD 9010014631 6.0 TI 11.4MM OFFSET
• 00763000360283: ROD 9010014630 5.5 TI 14.2MM OFFSET
• 00763000360276: ROD 9010014629 5.5 TI 13.8MM OFFSET
• 00763000360245: ROD 9010014626 5.5 TI 12.8MM OFFSET
• 00763000360191: ROD 9010014621 6.0 CCM+ 13.5MM OFFSET
• 00763000360153: ROD 9010014617 6.0 CCM+ 11.4MM OFFSET
• 00763000360146: ROD 9010014616 5.5 CCM+ 14.2MM OFFSET
• 00763000360139: ROD 9010014615 5.5 CCM+ 13.8MM OFFSET
• 00763000360122: ROD 9010014614 5.5 CCM+ 13.5MM OFFSET
• 00763000360115: ROD 9010014613 5.5 CCM+ 13.1MM OFFSET
• 00763000360108: ROD 9010014612 5.5 CCM+ 12.8MM OFFSET
• 00763000360092: ROD 9010014611 5.5 CCM+ 12MM OFFSET
• 00763000360085: ROD 9010014610 5.5 CCM+ 11.4MM OFFSET
• 00763000360351: ROD 9010014637 6.0 TI 14.2MM OFFSET
• 00763000360269: ROD 9010014628 5.5 TI 13.5MM OFFSET
• 00763000360252: ROD 9010014627 5.5 TI 13.1MM OFFSET
• 00763000360238: ROD 9010014625 5.5 TI 12MM OFFSET
• 00763000360221: ROD 9010014624 5.5 TI 11.4MM OFFSET
• 00763000360214: ROD 9010014623 6.0 CCM+ 14.2MM OFFSET
• 00763000360207: ROD 9010014622 6.0 CCM+ 13.8MM OFFSET
• 00763000360184: ROD 9010014620 6.0 CCM+ 13.1MM OFFSET
• 00763000360177: ROD 9010014619 6.0 CCM+ 12.8MM OFFSET
• 00763000360160: ROD 9010014618 6.0 CCM+ 12MM OFFSET
• 00763000534592: HOOK 5445122 4.75 NARROW XS SHORT BLADE
• 00763000534578: HOOK 5445101 4.75 PEDICLE XS SHORT BLADE