VyLink™

GUDID 00840283400834

X-Link, Single, 6.0x50mm, Ti 6Al-4V

VY SPINE LLC

Bone-screw internal spinal fixation system connector

• Primary Device ID: 00840283400834
• NIH Device Record Key: 5afddc2b-547a-43ef-b0c9-c3f8b6af39db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VyLink™
• Version Model Number: 04-XS-6050-TI-N
• Company DUNS: 049592888
• Company Name: VY SPINE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com
• Phone: 866-489-7746
• Email: info@vyspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840283400834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213750

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

[00840283400834]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-26
• Device Publish Date: 2024-08-16

On-Brand Devices [VyLink™]

• 00840283400858: X-Link, Single, 6.0x90mm, Ti 6Al-4V
• 00840283400841: X-Link, Single, 6.0x75mm, Ti 6Al-4V
• 00840283400834: X-Link, Single, 6.0x50mm, Ti 6Al-4V
• 00840283400827: X-Link, Single, 6.0x35mm, Ti 6Al-4V