VERTE-SPAN® Spinal System

GUDID 20721902068342

M4 BREAK-OFF SCREW

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 20721902068342
• NIH Device Record Key: 7ffdfc70-dafc-4599-add7-4382c1ee0b6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERTE-SPAN® Spinal System
• Version Model Number: 8914000
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 2
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902068348 [Unit of Use]
GS1	20721902068342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010930

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[20721902068342]

Moist Heat or Steam Sterilization

[20721902068342]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-29

On-Brand Devices [VERTE-SPAN® Spinal System]

• 00721902035388: OTHER 8913105 VRTSPN THORACIC CYLINDER L
• 00721902035289: OTHER 8912200 VERTSPN THORACOLUMBAR RT E
• 00721902035234: OTHER 8912010 VERTSPN THORACOLUMBAR CYLI
• 20721902068342: M4 BREAK-OFF SCREW