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.

• 00199150023035 - Medtronic Reusable Instruments: 2025-09-09 INSERTER X1124001 TLIF RATCHETING
• 00199150023042 - Medtronic Reusable Instruments: 2025-09-09 INSERTER X1124002 RATCHETING KNOB
• 00763000874520 - SHILLA™ Growth Guidance System: 2025-09-09 SCREW 7673520 4.5 SHILLA FAS 5.5X20
• 00763000856663 - VERTE-STACK® Spinal System: 2025-09-08 IMPLANT 6240264 ANATOMIC 16X14X12MM
• 00763000856670 - VERTE-STACK® Spinal System: 2025-09-08 IMPLANT 6240364 ANATOMIC 16X14X13MM
• 00763000856687 - VERTE-STACK® Spinal System: 2025-09-08 IMPLANT 6240464 ANATOMIC 16X14X14MM
• 00763000856847 - VERTE-STACK® Spinal System: 2025-09-08 IMPLANT 6240541 ANATOMIC 14X11X5MM
• 00763000856892 - VERTE-STACK® Spinal System: 2025-09-08 IMPLANT 6240041 ANATOMIC 14X11X10MM