CD HORIZON® SOLERA Spinal System

GUDID 00643169652804

ROD X0914083 DUAL BEND 5.5 CCM PLS X 490

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00643169652804
• NIH Device Record Key: 9ed67dc8-6335-4dd9-a031-fb5582b19432
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD HORIZON® SOLERA Spinal System
• Version Model Number: X0914083
• 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
• 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	00643169652804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121680

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

[00643169652804]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-16
• Device Publish Date: 2024-07-08

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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• 00763000855215 - n/a: 2025-06-06 INSTRUMENT 6248864 8X16X14 TRIAL
• 00763000889159 - ATLANTIS® Anterior Cervical Plate System: 2025-06-06 SCREW 3120315 4.0 X 15 SELF TAP VAR
• 00763000889166 - ATLANTIS® Anterior Cervical Plate System: 2025-06-06 SCREW 3120314 4.0 X 14 SELF TAP VAR
• 00763000889173 - ATLANTIS® Anterior Cervical Plate System: 2025-06-06 SCREW 3120313 4.0 X 13 SELF TAP VAR
• 00763000889227 - ATLANTIS® Anterior Cervical Plate System: 2025-06-06 SCREW 3125313 4.5 X 13 SELF TAP VAR
• 00763000889319 - ATLANTIS® Anterior Cervical Plate System: 2025-06-06 SCREW 3120214 4.0 X 14 SELF TAP FIX
• 00763000889425 - ATLANTIS® Anterior Cervical Plate System: 2025-06-06 SCREW 3120514 4.0 X 14 SELF DRILL VAR