GUDID 00763000855123

INSTRUMENT 6248564 5X16X14 TRIAL

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00763000855123
• NIH Device Record Key: 58a88a31-676e-4426-b905-e1d04a412a81
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6248564
• 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	00763000855123 [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

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

Moist Heat or Steam Sterilization

[00763000855123]

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.

• 00763000857349 - VERTE-STACK® Spinal System: 2025-01-07 SPACER 6272044 PSR STRUT 44 X 14 X 11MM
• 00763000857493 - VERTE-STACK® Spinal System: 2025-01-07 SPACER 6287141 PSR LAT PORTS 11X14X11
• 00763000857530 - VERTE-STACK® Spinal System: 2025-01-07 SPACER 6287641 PSR LAT PORTS 6X14X11
• 00763000650254 - CD Horizon™ ModuLeX™ FNS Screw Set: 2025-01-06 SHANK 55900524530 CANN OG FNS 4.5X30 TI
• 00763000650261 - CD Horizon™ ModuLeX™ FNS Screw Set: 2025-01-06 SHANK 55900524535 CANN OG FNS 4.5X35 TI
• 00763000650278 - CD Horizon™ ModuLeX™ FNS Screw Set: 2025-01-06 SHANK 55900524540 CANN OG FNS 4.5X40 TI
• 00763000650285 - CD Horizon™ ModuLeX™ FNS Screw Set: 2025-01-06 SHANK 55900524545 CANN OG FNS 4.5X45 TI
• 00763000650292 - CD Horizon™ ModuLeX™ FNS Screw Set: 2025-01-06 SHANK 55900524550 CANN OG FNS 4.5X50 TI