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.

• 00763000681401 - CD HORIZON® Spinal System: 2025-07-18 75753019 INSTRUMENT MULTILVL OUTR EXTNDR
• 00763000681432 - CD HORIZON® Spinal System: 2025-07-18 INSTRUMENT 7576305 REDUCTION INNER SLEEV
• 00763000681449 - CD HORIZON® Spinal System: 2025-07-18 INSTRUMENT 7576301 REDCTN OUTR EXTNDR ML
• 00763000681456 - CD HORIZON® Spinal System: 2025-07-18 INSTRUMENT 7576302 REDCTN MDL EXTNDR ML
• 00763000681463 - CD HORIZON® Spinal System: 2025-07-18 INSTRUMENT 7576303 REDUCTION EXTNDR A SL
• 00763000684426 - CD HORIZON® Spinal System: 2025-07-18 ROD 7575300 INSERTER
• 00763000684433 - CD HORIZON® Spinal System: 2025-07-18 75753059 INSTRUMENT EXTNDER INNER SLEEVE
• 00763000684440 - CD HORIZON® Spinal System: 2025-07-18 75753029 INSTRUMENT MULTILEVL MID EXTNDR