MSB VERTE-STACK Spinal System

GUDID 00885074036175

INSTRUMENT 3289400 INSERTER HANDLE

MEDTRONIC SOFAMOR DANEK, INC.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00885074036175
• NIH Device Record Key: d4faa34c-3d9f-4abc-aeda-f455b53655d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MSB VERTE-STACK Spinal System
• Version Model Number: 3289400
• 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: false
• 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	00885074036175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090353

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

[00885074036175]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-14
• Device Publish Date: 2024-10-05

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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• 00199150014149 - Medtronic Reusable Instruments: 2025-07-08 SPREADER X0625000 MODULAR
• 00199150014156 - Medtronic Reusable Instruments: 2025-07-08 DISTRACTOR X0625001 MODULAR TIP 30MM RH
• 00199150014163 - Medtronic Reusable Instruments: 2025-07-08 DISTRACTOR X0625002 MODULAR TIP 30MM LH
• 00199150014170 - Medtronic Reusable Instruments: 2025-07-08 DISTRACTOR X0625003 MODULAR TIP 35MM RH
• 00199150014187 - Medtronic Reusable Instruments: 2025-07-08 DISTRACTOR X0625004 MODULAR TIP 35MM LH