Titan Inserter

GUDID 00763000402594

INSERTER X0420002 ENDO TO INSERTER

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00763000402594
• NIH Device Record Key: 41451e28-e776-4264-9e80-94ad117db172
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan Inserter
• Version Model Number: X0420002
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000402594 [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

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

[00763000402594]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-06
• Device Publish Date: 2020-10-29

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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• 00763000873639 - DIVERGENCE® ANTERIOR CERVICAL FUSION SYSTEM: 2025-04-18 SCREW PK2 G7743513 MINIP S-T 3.5MM X13MM
• 00643169699885 - PIVOX™ Oblique Lateral Spinal System: 2025-04-14 TRAY 2201006 PIVOX PLATE INSTRUMENTS
• 00763000855741 - PYRAMESH® C Titanium Mesh: 2025-04-14 MESH 9051790 PYRM IMPL 17MMX22MMX90MM
• 00763000855888 - PYRAMESH® Implant System: 2025-04-14 MESH 9052830 PYRAMESH IMP 22MMX28MMX30MM
• 00763000964429 - CD Horizon™ ModuLeX™ Spinal System: 2025-04-14 HOOK 5593001 STERILE PEDICLE SM
• 00763000964436 - CD Horizon™ ModuLeX™ Spinal System: 2025-04-14 HOOK 5593002 STERILE PEDICLE MD
• 00763000964443 - CD Horizon™ ModuLeX™ Spinal System: 2025-04-14 HOOK 5593011 STERILE WIDE BLADE SM