VERTE-STACK Spinal System

GUDID 00613994305374

INSERTER 6246011 HANDLE OUTER

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic graft inserter

• Primary Device ID: 00613994305374
• NIH Device Record Key: 49547369-34ac-4bcc-b926-8ab7147b26d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERTE-STACK Spinal System
• Version Model Number: 6246011
• 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
• 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	00613994305374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070173

FDA Product Code

• MQP: Spinal vertebral body replacement device

Sterilization

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

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

[00613994305374]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-28
• Device Publish Date: 2021-12-20

On-Brand Devices [VERTE-STACK Spinal System]

• 00613994305374: INSERTER 6246011 HANDLE OUTER
• 00763000671525: INSERTER 6246011 HANDLE OUTER