VERTE-STACK Spinal System

GUDID 00613994305374

INSERTER 6246011 HANDLE OUTER

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic graft inserter Orthopaedic graft inserter Orthopaedic graft inserter Orthopaedic graft inserter Orthopaedic graft inserter Orthopaedic graft inserter Orthopaedic graft inserter Orthopaedic graft inserter Orthopaedic graft inserter Orthopaedic graft inserter Orthopaedic graft inserter Orthopaedic graft inserter Orthopaedic graft inserter Orthopaedic graft inserter Orthopaedic graft inserter 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

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

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

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000085353 - ARTiC-L™ Spinal System: 2024-06-28 TRIAL 5251100 L 25 HT 11 DEG 0 FIXED
• 00763000700485 - MSB Reusable Instruments: 2024-06-28 OSTEOTOME EX0222042 STRAIGHT 12.7MM
• 00613994104441 - MSB Reusable Instruments: 2024-06-24 INSTRUMENT X0805222 RIGHT HALF TUBE90MM
• 00763000359720 - CD HORIZON® Spinal System: 2024-06-24 MODULE 7050534R CDHL HOOK STAGING MOD
• 00763000917975 - MSB Reusable Instruments: 2024-06-24 RETRACTOR EX0823013 HAND HELD TISSUE
• 00763000920159 - MSB Reusable Instruments: 2024-06-24 SPREADER EX0323002 LAMINA ANGLED
• 00885074417615 - CAPSTONE® Spinal System: 2024-06-24 INSERTER X0105157 THREADED
• 00885074309620 - n/a: 2024-06-03 INSTRUMENT 6971105 SHIM DISTRACTOR 5MM