VyLink™
GUDID 00840283403293
Tap, 4.0
VY SPINE LLC
Internal spinal fixation procedure kit, reusable| Primary Device ID | 00840283403293 |
| NIH Device Record Key | 866fe431-8b13-4f24-a9c1-6137031ab15a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VyLink™ |
| Version Model Number | 04-IT-040 |
| 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 | 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 | 866-489-7746 |
| info@vyspine.com | |
| Phone | 866-489-7746 |
| info@vyspine.com | |
| Phone | 866-489-7746 |
| info@vyspine.com | |
| Phone | 866-489-7746 |
| info@vyspine.com | |
| Phone | 866-489-7746 |
| info@vyspine.com | |
| Phone | 866-489-7746 |
| info@vyspine.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840283403293 [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 |
[00840283403293]
Moist Heat or Steam Sterilization
[00840283403293]
Moist Heat or Steam Sterilization
[00840283403293]
Moist Heat or Steam Sterilization
[00840283403293]
Moist Heat or Steam Sterilization
[00840283403293]
Moist Heat or Steam Sterilization
[00840283403293]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-31 |
| Device Publish Date | 2026-03-23 |
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 |
Trademark Results [VyLink]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VYLINK 78665470 not registered Dead/Abandoned |
Bristol-Myers Squibb Company 2005-07-07 |
 VYLINK 73132470 1105534 Dead/Expired |
BRAND-REX COMPANY 1977-06-30 |
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