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.

• 00763000665173 - ZEVO™ Anterior Cervical Plate System: 2025-03-05 SCREW G7713515 ZEVO VAR SD 3.5MM X 15MM
• 00643169468771 - CD HORIZON® Spinal System: 2025-03-03 DRIVER X1013216 STEP 5.5/6.0 RMAS SOLID
• 00763000855024 - n/a: 2025-02-28 INSTRUMENT 6248241 12X14X11 TRIAL
• 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