GUDID 00763000855116

INSTRUMENT 6248541 5X14X11 TRIAL

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00763000855116
• NIH Device Record Key: bc252da5-db4f-4d21-8323-0cdfa9b9d0aa
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6248541
• 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	00763000855116 [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

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

Moist Heat or Steam Sterilization

[00763000855116]

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.

• 00199150026951 - Medtronic Reusable Instruments: 2025-08-19 HANDLE X0525002 RETRACTOR BLADE
• 00199150027651 - Medtronic Reusable Instruments: 2025-08-19 ADAPTER X5598045 BREAKOFF DRIVER
• 00763000880194 - n/a: 2025-08-19 AWL 7967082 U-JOINT
• 00763000884499 - n/a: 2025-08-19 GUIDE 7080903 FIXED DRILL GUIDE
• 00763000884505 - n/a: 2025-08-19 GUIDE 7080904 VARIABLE DRILL GUIDE
• 00763000884574 - n/a: 2025-08-19 AWL 7080911 FIXED ANGLE AWL
• 00763000664091 - ZEVO™ Anterior Cervical Plate System: 2025-08-15 PLATE G3005079 ZEVO 79MM 5 LVL
• 00763000664114 - ZEVO™ Anterior Cervical Plate System: 2025-08-15 PLATE G3005085 ZEVO 85MM 5 LVL