GUDID 00763000855093

INSTRUMENT 6248464 14X16X14 TRIAL

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00763000855093
• NIH Device Record Key: dbe8ff42-3187-41dd-be8e-c5a2812548bb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6248464
• 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	00763000855093 [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

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

Moist Heat or Steam Sterilization

[00763000855093]

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.

• 00763000857431 - VERTE-STACK® Spinal System: 2025-03-14 SPACER 6286511 PSR LAT PORTS 5X11X11
• 00763000864637 - n/a: 2025-03-14 TOOL 4360002 END CAP REMOVAL TOOL
• 00763000864644 - n/a: 2025-03-14 TOOL 4360320 IMPLANT REMOVAL TOOL
• 00763000864668 - T2™ Spinal System: 2025-03-14 DRIVER 4360520 T17 DRIVER
• 00763000862909 - General Instruments: 2025-03-11 DRIVER X981000033 RETAINING STRAIGHT T25
• 00763000862916 - General Instruments: 2025-03-11 AWL X981000035 AWL ANGLED
• 00763000862930 - General Instruments: 2025-03-11 DRIVER X981000036 RETAINING 40 DEG T25
• 00763000862947 - General Instruments: 2025-03-11 DRIVER X981000136 40DEG T25 DRIVER