CD Horizon™ Modular 5.5/6.0mm Spinal System

GUDID 00763000279059

TRAY 5599301 MODULAR INSTRUMENT LOWER

MEDTRONIC SOFAMOR DANEK, INC.

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• Primary Device ID: 00763000279059
• NIH Device Record Key: d8f0ac6f-b481-4a49-af4a-c3995ab5ca70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD Horizon™ Modular 5.5/6.0mm Spinal System
• Version Model Number: 5599301
• 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
• 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
• 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	00763000279059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201407

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

[00763000279059]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-02
• Device Publish Date: 2020-10-24

On-Brand Devices [CD Horizon™ Modular 5.5/6.0mm Spinal System]

• 00763000279233: LID 5599303 MODULAR SCREW SHANK CADDY
• 00763000279226: TRAY 5599302 MODULAR SCREW SHANK
• 00763000279066: TRAY 5599304 MODULAR DRIVER
• 00763000279059: TRAY 5599301 MODULAR INSTRUMENT LOWER
• 00763000279042: TRAY 5599300 MODULAR INSTRUMENT UPPER