ENDOSKELETON® TCS

GUDID 00763000879594

INSERTER 5210-1021 TCS INSERTER

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: 00763000879594
• NIH Device Record Key: 50ffaf20-25de-400b-a014-4af64e49c6b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TCS
• Version Model Number: 5210-1021
• 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: 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000879594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142940

FDA Product Code

• HWR: DRIVER, PROSTHESIS

Sterilization

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

[00763000879594]

Moist Heat or Steam Sterilization

[00763000879594]

Moist Heat or Steam Sterilization

[00763000879594]

Moist Heat or Steam Sterilization

[00763000879594]

Moist Heat or Steam Sterilization

[00763000879594]

Moist Heat or Steam Sterilization

[00763000879594]

Moist Heat or Steam Sterilization

[00763000879594]

Moist Heat or Steam Sterilization

[00763000879594]

Moist Heat or Steam Sterilization

[00763000879594]

Moist Heat or Steam Sterilization

[00763000879594]

Moist Heat or Steam Sterilization

[00763000879594]

Moist Heat or Steam Sterilization

[00763000879594]

Moist Heat or Steam Sterilization

[00763000879594]

Moist Heat or Steam Sterilization

[00763000879594]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-04
• Device Publish Date: 2025-07-25

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000839598 - Medtronic Reusable Instruments: 2025-09-23 BLADE X07310017 DILATOR 4 SLIM
• 00763000684068 - Medtronic Reusable Instruments: 2025-09-16 INSTRUMENT 9339010 MODULAR DRILL HANDLE
• 00763000684112 - N/A: 2025-09-16 INSTRUMENT 9339095 CALIPER
• 00763000884833 - N/A: 2025-09-16 INSTRUMENT 7081912 DTS GUIDE
• 00763000885076 - N/A: 2025-09-16 DRILL BIT 7080613 NON STERILE 13MM
• 00763000885274 - N/A: 2025-09-16 TRAIL 8740041 10X14X11 CORNERSTONE SR
• 00763000885281 - N/A: 2025-09-16 TRAIL 8740141 11X14X11 CORNERSTONE SR
• 00763000885298 - N/A: 2025-09-16 TRAIL 8740241 12X14X11 CORNERSTONE SR