VyLink™

GUDID 00840283402715

5.5 System, Poly Standard Solid Screw, Ø6.5x35mm, Ti 6AL-4V

VY SPINE LLC

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840283402715
• NIH Device Record Key: d4f2c8e8-c547-417b-b015-0a76b070fd2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VyLink™
• Version Model Number: 04-5P-SS-6535-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840283402715 [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

[00840283402715]

Moist Heat or Steam Sterilization

[00840283402715]

Moist Heat or Steam Sterilization

[00840283402715]

Moist Heat or Steam Sterilization

[00840283402715]

Moist Heat or Steam Sterilization

[00840283402715]

Moist Heat or Steam Sterilization

[00840283402715]

Moist Heat or Steam Sterilization

[00840283402715]

Moist Heat or Steam Sterilization

[00840283402715]

Moist Heat or Steam Sterilization

[00840283402715]

Moist Heat or Steam Sterilization

[00840283402715]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-16
• Device Publish Date: 2026-03-06

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
• 00840283401435: Swivel Rod Connector Counter Torque
• 00840283403118: Rod, Curved, Ø5.5x110, Ti 6AL-4V
• 00840283402890: 5.5 System, Poly Standard Solid Screw, Ø8.5x35mm, Ti 6AL-4V
• 00840283402784: 5.5 System, Poly Standard Solid Screw, Ø6.5x70mm, Ti 6AL-4V
• 00840283402685: 5.5 System, Poly Standard Solid Screw, Ø5.5x55mm, Ti 6AL-4V
• 00840283402609: 5.5 System, Poly Standard Solid Screw, Ø4.5x40mm, Ti 6AL-4V
• 00840283402593: 5.5 System, Poly Standard Solid Screw, Ø4.5x35mm, Ti 6AL-4V
• 00840283402586: 5.5 System, Poly Standard Solid Screw, Ø4.5x30mm, Ti 6AL-4V
• 00840283402579: 5.5 System, Poly Standard Solid Screw, Ø4.5x25mm, Ti 6AL-4V
• 00840283403132: Rod, Curved, Ø5.5x130, Ti 6AL-4V
• 00840283402968: 5.5 System, Poly Standard Solid Screw, Ø8.5x70mm, Ti 6AL-4V
• 00840283402869: 5.5 System, Poly Standard Solid Screw, Ø7.5x60mm, Ti 6AL-4V
• 00840283402814: 5.5 System, Poly Standard Solid Screw, Ø7.5x35mm, Ti 6AL-4V
• 00840283402807: 5.5 System, Poly Standard Solid Screw, Ø7.5x30mm, Ti 6AL-4V
• 00840283402777: 5.5 System, Poly Standard Solid Screw, Ø6.5x65mm, Ti 6AL-4V
• 00840283402753: 5.5 System, Poly Standard Solid Screw, Ø6.5x55mm, Ti 6AL-4V
• 00840283402722: 5.5 System, Poly Standard Solid Screw, Ø6.5x40mm, Ti 6AL-4V
• 00840283402715: 5.5 System, Poly Standard Solid Screw, Ø6.5x35mm, Ti 6AL-4V
• 00840283402654: 5.5 System, Poly Standard Solid Screw, Ø5.5x40mm, Ti 6AL-4V
• 00840283402647: 5.5 System, Poly Standard Solid Screw, Ø5.5x35mm, Ti 6AL-4V
• 00840283403125: Rod, Curved, Ø5.5x120, Ti 6AL-4V
• 00840283403101: Rod, Curved, Ø5.5x100, Ti 6AL-4V
• 00840283403002: Rod, Curved, Ø5.5x35, Ti 6AL-4V
• 00840283402999: Rod, Curved, Ø5.5x30, Ti 6AL-4V
• 00840283402982: 5.5 System, Poly Standard Solid Screw, Ø8.5x80mm, Ti 6AL-4V
• 00840283402975: 5.5 System, Poly Standard Solid Screw, Ø8.5x75mm, Ti 6AL-4V
• 00840283402951: 5.5 System, Poly Standard Solid Screw, Ø8.5x65mm, Ti 6AL-4V
• 00840283402944: 5.5 System, Poly Standard Solid Screw, Ø8.5x60mm, Ti 6AL-4V
• 00840283402937: 5.5 System, Poly Standard Solid Screw, Ø8.5x55mm, Ti 6AL-4V
• 00840283402920: 5.5 System, Poly Standard Solid Screw, Ø8.5x50mm, Ti 6AL-4V
• 00840283402913: 5.5 System, Poly Standard Solid Screw, Ø8.5x45mm, Ti 6AL-4V
• 00840283402906: 5.5 System, Poly Standard Solid Screw, Ø8.5x40mm, Ti 6AL-4V
• 00840283402883: 5.5 System, Poly Standard Solid Screw, Ø7.5x70mm, Ti 6AL-4V
• 00840283402876: 5.5 System, Poly Standard Solid Screw, Ø7.5x65mm, Ti 6AL-4V
• 00840283402852: 5.5 System, Poly Standard Solid Screw, Ø7.5x55mm, Ti 6AL-4V
• 00840283402845: 5.5 System, Poly Standard Solid Screw, Ø7.5x50mm, Ti 6AL-4V
• 00840283402821: 5.5 System, Poly Standard Solid Screw, Ø7.5x40mm, Ti 6AL-4V
• 00840283402791: 5.5 System, Poly Standard Solid Screw, Ø7.5x25mm, Ti 6AL-4V
• 00840283402760: 5.5 System, Poly Standard Solid Screw, Ø6.5x60mm, Ti 6AL-4V
• 00840283402746: 5.5 System, Poly Standard Solid Screw, Ø6.5x50mm, Ti 6AL-4V
• 00840283402739: 5.5 System, Poly Standard Solid Screw, Ø6.5x45mm, Ti 6AL-4V
• 00840283402708: 5.5 System, Poly Standard Solid Screw, Ø6.5x30mm, Ti 6AL-4V
• 00840283402692: 5.5 System, Poly Standard Solid Screw, Ø6.5x25mm, Ti 6AL-4V
• 00840283402678: 5.5 System, Poly Standard Solid Screw, Ø5.5x50mm, Ti 6AL-4V
• 00840283402661: 5.5 System, Poly Standard Solid Screw, Ø5.5x45mm, Ti 6AL-4V
• 00840283402630: 5.5 System, Poly Standard Solid Screw, Ø5.5x30mm, Ti 6AL-4V