Endoskeleton™ TT Interbody System with Titan nanoLOCK™ Surface Technology

GUDID 00763000885755

NANO SPACER 4114-3509-N TT 4 DG XLG 9MM

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00763000885755
• NIH Device Record Key: 507e3b42-7033-4fa3-945a-4ebabb06c50c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton™ TT Interbody System with Titan nanoLOCK™ Surface Technology
• Version Model Number: 4114-3509-N
• 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
• 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	00763000885755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141953

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-24
• Device Publish Date: 2025-06-16

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000679675 - POWEREASE™ Instruments: 2025-08-05 SLEEVE 2342402 LOCKING MPA SLEEVE
• 00763000679682 - POWEREASE™ Instruments: 2025-08-05 SLEEVE 2343435 15MM SLEEVE
• 00763000671525 - VERTE-STACK Spinal System: 2025-08-04 INSERTER 6246011 HANDLE OUTER
• 00763000674458 - Medtronic Resuable Instruments: 2025-08-04 FREEHAND HOLDER 9877701 LORDOTIC 3-HOLE
• 00763000679415 - Medtronic Resuable Instruments: 2025-08-04 GUIDE 9874133 DBL BARREL 0 DEG
• 00763000679460 - Medtronic Resuable Instruments: 2025-08-04 HOLDER 9870001 4HOLE PLATE FREE HAND
• 00763000679538 - Medtronic Resuable Instruments: 2025-08-04 PLATE HOLDER 9874640 4 HOLE
• 00763000679545 - Medtronic Resuable Instruments: 2025-08-04 HOLDER 9874145 STAND ALONE