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.

• 00763000855017 - n/a: 2025-06-06 INSTRUMENT 6248186 11X18X16 TRIAL
• 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