Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology

GUDID 00763000885977

NANO SPACER 5386-1605-N TCS 6 DEG LG 5MM

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00763000885977
• NIH Device Record Key: 3cd7d3e3-0675-47ab-a25f-3ff28c2ffb09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology
• Version Model Number: 5386-1605-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000885977 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151596

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

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: 2025-05-09
• Device Publish Date: 2025-05-01

On-Brand Devices [Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology]

• 00763000886042: NANO SPACER 5386-1612-N TCS 6 DG LG 12MM
• 00763000886035: NANO SPACER 5386-1611-N TCS 6 DG LG 11MM
• 00763000886028: NANO SPACER 5386-1610-N TCS 6 DG LG 10MM
• 00763000886004: NANO SPACER 5386-1608-N TCS 6 DEG LG 8MM
• 00763000885984: NANO SPACER 5386-1606-N TCS 6 DEG LG 6MM
• 00763000885977: NANO SPACER 5386-1605-N TCS 6 DEG LG 5MM
• 00763000885939: NANO SPACER 5366-1409-N TCS 6 DEG MD 9MM
• 00763000885922: NANO SPACER 5366-1408-N TCS 6 DEG MD 8MM
• 00763000885892: NANO SPACER 5366-1405-N TCS 6 DEG MD 5MM
• 00763000885878: NANO SPACER 5346-1211-N TCS 6 DG SM 11MM
• 00763000885953: NANO SPACER 5366-1411-N TCS 6 DG MD 11MM
• 00763000885915: NANO SPACER 5366-1407-N TCS 6 DEG MD 7MM
• 00763000885908: NANO SPACER 5366-1406-N TCS 6 DEG MD 6MM
• 00763000885854: NANO SPACER 5346-1209-N TCS 6 DEG SM 9MM
• 00763000885823: NANO SPACER 5346-1206-N TCS 6 DEG SM 6MM