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.

• 00763000663865 - n/a: 2025-07-28 DRILL BIT 7080513 STERILE 13MM
• 00763000856472 - Pyramesh® Implant System: 2025-07-28 MESH 905-412 PYRM 10 X 14 OVOID X 12MM
• 00763000856489 - Pyramesh® Implant System: 2025-07-28 MESH 905-415 PYRM 10 X 14 OVOID X 15MM
• 00763000856502 - Pyramesh® Implant System: 2025-07-28 MESH 905-508 PYRM 13 X 17 OVOID X 8MM
• 00763000856519 - Pyramesh® Implant System: 2025-07-28 MESH 905-509 PYRM 13 X 17 OVOID X 9MM
• 00763000856526 - Pyramesh® Implant System: 2025-07-28 MESH 905-511 PYRM 13 X 17 OVOID X 11MM
• 00763000856533 - Pyramesh® Implant System: 2025-07-28 MESH 905-512 PYRM 13 X 17 OVOID X 12MM
• 00763000856557 - Pyramesh® Implant System: 2025-07-28 MESH 905-520 PYRM 13 X 17 OVOID X 20MM