Endoskeleton™ TT Interbody System

GUDID 00763000584924

HOLDER 1000-1478 ENDO TT 15 DEG CURVED

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00763000584924
• NIH Device Record Key: 0364a592-46f8-44df-bea0-a1e1a3850215
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton™ TT Interbody System
• Version Model Number: 1000-1478
• 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
• 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	00763000584924 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083714

FDA Product Code

• HWR: DRIVER, PROSTHESIS

Sterilization

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

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

[00763000584924]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-06
• Device Publish Date: 2021-11-27

On-Brand Devices [Endoskeleton™ TT Interbody System]

• 00763000584924: HOLDER 1000-1478 ENDO TT 15 DEG CURVED
• 00763000879310: PUSHER 4200-1021 TT THIN PUSHER
• 00763000879303: PUSHER 4200-1003 TT STRAIGHT PUSHER