GUDID 00763000855109

INSTRUMENT 6248486 14X18X16 TRIAL

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00763000855109
• NIH Device Record Key: 536bb576-ef58-4d84-aa67-570c023c984f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6248486
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000855109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112444

FDA Product Code

• MQP: Spinal vertebral body replacement device

Sterilization

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

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

[00763000855109]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-14
• Device Publish Date: 2024-10-04

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000857189 - VERTE-STACK® Spinal System: 2025-02-21 SPACER 6277541 CORNERSTONE PSR 5X14X11MM
• 00763000857196 - VERTE-STACK® Spinal System: 2025-02-21 SPACER 6277641 CORNERSTONE PSR 6X14X11MM
• 00763000857202 - VERTE-STACK® Spinal System: 2025-02-21 SPACER 6277741 CORNERSTONE PSR 7X14X11MM
• 00763000857219 - VERTE-STACK® Spinal System: 2025-02-21 SPACER 6277841 CORNERSTONE PSR 8X14X11MM
• 00763000857226 - VERTE-STACK® Spinal System: 2025-02-21 SPACER 6277941 CORNERSTONE PSR 9X14X11MM
• 00763000857509 - VERTE-STACK® Spinal System: 2025-02-21 SPACER 6287241 PSR LAT PORTS 12X14X11
• 00763000857516 - VERTE-STACK® Spinal System: 2025-02-21 SPACER 6287341 PSR LAT PORTS 13X14X11
• 00763000857547 - VERTE-STACK® Spinal System: 2025-02-21 SPACER 6287741 PSR LAT PORTS 7X14X11