Navigated INFINITY™ Occipitocervical Upper Thoracic System

GUDID 00643169799936

DRILL BIT NAVG3606010 NAVIGATED

MEDTRONIC SOFAMOR DANEK, INC.

Fluted surgical drill bit, single-use, sterile

• Primary Device ID: 00643169799936
• NIH Device Record Key: 43d1a206-110d-49a4-96d1-0f16a3e312be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigated INFINITY™ Occipitocervical Upper Thoracic System
• Version Model Number: NAVG3606010
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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
• 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	00643169799936 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181111

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-07-30

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• 00199150024469 - INFINITY™ Occipitocervical Upper Thoracic System: 2026-03-30 DRIVER NAV3650005 NAV RMAS RETAINING
• 00199150024483 - INFINITY™ Occipitocervical Upper Thoracic System: 2026-03-30 DRIVER NAV3606200 NAV MAS LOCKING SCREW
• 00199150038138 - INFINITY™ Occipitocervical Upper Thoracic System: 2026-03-30 NAV TAP NAV3650030 TAP 3.0MM PLUS
• 00199150039524 - n/a: 2026-03-30 SET SCREW STARTER 3650004 MT15 RETAINING
• 00199150044016 - Medtronic Reusable Instruments and Accessories: 2026-03-30 5.5/6.0 TITANIUM TAB EXTENDER-6550025
• 00199150051212 - Medtronic Reusable Instruments and Accessories: 2026-03-30 TRAY RBT090101 STEALTH AXIS AUTOPLT TAPS