ENDOSKELETON® TCS Sterile Barrier System

GUDID 00763000880774

BONE SCRW 5301-3816-S TCS 3.8MM STD 16MM

MEDTRONIC SOFAMOR DANEK, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00763000880774
• NIH Device Record Key: 10a6e46d-60ed-486e-bae9-48248578e726
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TCS Sterile Barrier System
• Version Model Number: 5301-3816-S
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000880774 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173535

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: 2025-07-28
• Device Publish Date: 2025-07-18

On-Brand Devices [ENDOSKELETON® TCS Sterile Barrier System]

• 00763000881719: BONE SCRW 5302-3818-S TCS 3.8MM LCK 18MM
• 00763000880842: BONE SCRW 5302-3816-S TCS 3.8MM LCK 16MM
• 00763000880835: BONE SCRW 5302-3814-S TCS 3.8MM LCK 14MM
• 00763000880828: BONE SCRW 5302-3518-S TCS 3.5MM LCK 18MM
• 00763000880811: BONE SCRW 5302-3516-S TCS 3.5MM LCK 16MM
• 00763000880804: BONE SCRW 5302-3514-S TCS 3.5MM LCK 14MM
• 00763000880798: BONE SCRW 5302-3513-S TCS 3.5MM LCK 13MM
• 00763000880781: BONE SCRW 5301-3818-S TCS 3.8MM STD 18MM
• 00763000880774: BONE SCRW 5301-3816-S TCS 3.8MM STD 16MM
• 00763000880767: BONE SCRW 5301-3814-S TCS 3.8MM STD 14MM
• 00763000880750: BONE SCRW 5301-3518-S TCS 3.5MM STD 18MM
• 00763000880743: BONE SCRW 5301-3516-S TCS 3.5MM STD 16MM
• 00763000880736: BONE SCRW 5301-3514-S TCS 3.5MM STD 14MM
• 00763000880729: BONE SCRW 5301-3513-S TCS 3.5MM STD 13MM