Endoskeleton™ TCS Interbody System

GUDID 00763000879617

HANDLE 5210-1046 TCS RATCH TORQUE LIMIT

MEDTRONIC SOFAMOR DANEK, INC.

Surgical instrument handle, torque-limiting

• Primary Device ID: 00763000879617
• NIH Device Record Key: 90bd1b51-ea93-40e3-9c36-46f344061d8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton™ TCS Interbody System
• Version Model Number: 5210-1046
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	00763000879617 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00763000879617]

Moist Heat or Steam Sterilization

[00763000879617]

Moist Heat or Steam Sterilization

[00763000879617]

Moist Heat or Steam Sterilization

[00763000879617]

Moist Heat or Steam Sterilization

[00763000879617]

Moist Heat or Steam Sterilization

[00763000879617]

Moist Heat or Steam Sterilization

[00763000879617]

Moist Heat or Steam Sterilization

[00763000879617]

Moist Heat or Steam Sterilization

[00763000879617]

Moist Heat or Steam Sterilization

[00763000879617]

Moist Heat or Steam Sterilization

[00763000879617]

Moist Heat or Steam Sterilization

[00763000879617]

Moist Heat or Steam Sterilization

[00763000879617]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-12
• Device Publish Date: 2024-11-04

On-Brand Devices [Endoskeleton™ TCS Interbody System]

• 00763000406356: DRIVER 1000-0143 SHORT U-JOINT
• 00763000879617: HANDLE 5210-1046 TCS RATCH TORQUE LIMIT
• 00763000879624: EXTRACTOR 5210-1048 TCS BONE SCREW
• 00763000879549: RONGEUR 5210-1015 TCS RONGEUR