Endoskeleton™ TL Interbody System

GUDID 00191375052708

TRAY 1384-030-005 HL INSTRUMENTS SET 1

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray, reusable

• Primary Device ID: 00191375052708
• NIH Device Record Key: 648f035f-01c3-4d38-9ad8-20fb6c02d46e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton™ TL Interbody System
• Version Model Number: 1384-030-005
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• 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
• 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	00191375052708 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190840

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

[00191375052708]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-23
• Device Publish Date: 2024-08-15

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00721902301773 - n/a: 2026-02-23 INSTRUMENT 8670009 PAK 2 NEEDLE BEV TRO
• 00763000671495 - n/a: 2026-02-23 INSTRUMENT 6246086 18X16 RASP
• 00763000754853 - CD Horizon™ Spinal System: 2026-02-23 DOMINO 5932100332 TOP/TOP TI
• 00199150062973 - Medtronic Reusable Instruments: 2026-02-17 DRILL EX0120020 ANGLED
• 00199150065356 - Medtronic Reusable Instruments: 2026-02-17 DEROTATOR X1025036 SHAFT 5.5/6.0 RODS
• 00199150065363 - Medtronic Reusable Instruments: 2026-02-17 DEROTATOR X1025037 CLAMP
• 00199150065370 - Medtronic Reusable Instruments: 2026-02-17 DEROTATOR X1025038 HANDLE
• 00199150065387 - Medtronic Reusable Instruments: 2026-02-17 DEROTATOR X1025039 LINK ROD