VERTE-STACK®

GUDID 00763000857561

SPACER 6287941 PSR LAT PORTS 9X14X11

MEDTRONIC SOFAMOR DANEK, INC.

Vertebral body prosthesis

• Primary Device ID: 00763000857561
• NIH Device Record Key: 3dc6eee8-1c5a-4ee5-9e10-5302f9c11b70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERTE-STACK®
• Version Model Number: 6287941
• 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

Device Dimensions

• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter
• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter
• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter
• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter
• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter
• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter
• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter
• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter
• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter
• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter
• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter
• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter
• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter
• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter
• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter
• Height: 14 Millimeter
• Width: 9 Millimeter
• Depth: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000857561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052931

FDA Product Code

• MQP: Spinal vertebral body replacement device

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: 2025-04-07
• Device Publish Date: 2025-03-28

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