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

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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• 00763000855024 - n/a: 2025-02-28 INSTRUMENT 6248241 12X14X11 TRIAL
• 00763000857189 - VERTE-STACK® Spinal System: 2025-02-21 SPACER 6277541 CORNERSTONE PSR 5X14X11MM
• 00763000857196 - VERTE-STACK® Spinal System: 2025-02-21 SPACER 6277641 CORNERSTONE PSR 6X14X11MM
• 00763000857202 - VERTE-STACK® Spinal System: 2025-02-21 SPACER 6277741 CORNERSTONE PSR 7X14X11MM
• 00763000857219 - VERTE-STACK® Spinal System: 2025-02-21 SPACER 6277841 CORNERSTONE PSR 8X14X11MM
• 00763000857226 - VERTE-STACK® Spinal System: 2025-02-21 SPACER 6277941 CORNERSTONE PSR 9X14X11MM
• 00763000857509 - VERTE-STACK® Spinal System: 2025-02-21 SPACER 6287241 PSR LAT PORTS 12X14X11