INFINITY™ Occipitocervical Upper Thoracic System

GUDID 00763000990695

SET SCREW 3650315 MT15 NON BREAK OFF

MEDTRONIC MINIMED, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00763000990695
• NIH Device Record Key: 882bfc51-0bdf-4c31-8a72-c16ec61b1cb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFINITY™ Occipitocervical Upper Thoracic System
• Version Model Number: 3650315
• Company DUNS: 849626338
• Company Name: MEDTRONIC MINIMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000990695 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253129

FDA Product Code

• NKG: Posterior cervical screw system

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00763000990695]

Moist Heat or Steam Sterilization

[00763000990695]

Moist Heat or Steam Sterilization

[00763000990695]

Moist Heat or Steam Sterilization

[00763000990695]

Moist Heat or Steam Sterilization

[00763000990695]

Moist Heat or Steam Sterilization

[00763000990695]

Moist Heat or Steam Sterilization

[00763000990695]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-30
• Device Publish Date: 2026-03-22

Devices Manufactured by MEDTRONIC MINIMED, INC.

• 00763000990695 - INFINITY™ Occipitocervical Upper Thoracic System: 2026-03-30SET SCREW 3650315 MT15 NON BREAK OFF
• 00763000990695 - INFINITY™ Occipitocervical Upper Thoracic System: 2026-03-30 SET SCREW 3650315 MT15 NON BREAK OFF
• 00199150047000 - MiniMed 780G Insulin Pump: 2026-01-21 PUMP MMT-1884 780G US 6.62U A2.01 MG
• 00199150047024 - MiniMed 780G Insulin Pump: 2026-01-21 PUMP MMT-1884 780G US MG A2.01 6.62U PRB
• 00199150047048 - MiniMed 780G Insulin pump: 2026-01-21 KIT MMT-1894 780G US 6.62U A2.0X MG
• 00199150047055 - MiniMed 780G Insulin Pump: 2026-01-21 KIT MMT-1894MD 780G US GOV 6.62U A2.0X
• 00199150034123 - SFTWR MMT-6101 AHCL APP 3.1 ANDROID: 2025-10-06 SFTWR MMT-6101 AHCL APP 3.1 ANDROID
• 00199150034130 - MiniMed Mobile App: 2025-10-06 SFTWR MMT-6102 AHCL APP 3.1 IOS
• 00763000721350 - Simplera™: 2025-07-16 SFTWR MMT-8400 1.1 CGM MODULE IOS US