VySpan™

GUDID 00840283400674

Screw, 3.5x20mm, Ti 6Al-4V

VY SPINE LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840283400674
• NIH Device Record Key: c0ee1740-e82c-46a1-a7ef-b599404ab75c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VySpan™
• Version Model Number: 05-S-3520-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840283400674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213394

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

Moist Heat or Steam Sterilization

[00840283400674]

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 [VySpan™]

• 00840283400803: X-Link, Single, 3.5x90mm, Ti 6Al-4V
• 00840283400797: X-Link, Single, 3.5x75mm, Ti 6Al-4V
• 00840283400780: X-Link, Single, 3.5x50mm, Ti 6Al-4V
• 00840283400773: X-Link, Single, 3.5x35mm, Ti 6Al-4V
• 00840283400766: X-Link, Dual, 3.5x90mm, Ti 6Al-4V
• 00840283400759: X-Link, Dual, 3.5x75mm, Ti 6Al-4V
• 00840283400742: X-Link, Dual, 3.5x50mm, Ti 6Al-4V
• 00840283400735: X-Link, Dual, 3.5x35mm, Ti 6Al-4V
• 00840283400728: Screw, 4.0x20mm, Ti 6Al-4V
• 00840283400711: Screw, 4.0x18mm, Ti 6Al-4V
• 00840283400704: Screw, 4.0x16mm, Ti 6Al-4V
• 00840283400698: Screw, 4.0x14mm, Ti 6Al-4V
• 00840283400681: Screw, 4.0x12mm, Ti 6Al-4V
• 00840283400674: Screw, 3.5x20mm, Ti 6Al-4V
• 00840283400667: Screw, 3.5x18mm, Ti 6Al-4V
• 00840283400650: Screw, 3.5x16mm, Ti 6Al-4V
• 00840283400643: Screw, 3.5x14mm, Ti 6Al-4V
• 00840283400636: Screw, 3.5x12mm, Ti 6Al-4V
• 00840283400612: PCT Rod, Straight, 3.5x200mm, Ti 6Al-4V
• 00840283400605: PCT Rod, Curved, 3.5x100mm, Ti 6Al-4V
• 00840283400599: PCT Rod, Curved, 3.5x95mm, Ti 6Al-4V
• 00840283400582: PCT Rod, Curved, 3.5x90mm, Ti 6Al-4V
• 00840283400575: PCT Rod, Curved, 3.5x85mm, Ti 6Al-4V
• 00840283400568: PCT Rod, Curved, 3.5x80mm, Ti 6Al-4V
• 00840283400551: PCT Rod, Curved, 3.5x75mm, Ti 6Al-4V
• 00840283400544: PCT Rod, Curved, 3.5x70mm, Ti 6Al-4V
• 00840283400537: PCT Rod, Curved, 3.5x65mm, Ti 6Al-4V
• 00840283400520: PCT Rod, Curved, 3.5x60mm, Ti 6Al-4V
• 00840283400513: PCT Rod, Curved, 3.5x55mm, Ti 6Al-4V
• 00840283400506: PCT Rod, Curved, 3.5x50mm, Ti 6Al-4V
• 00840283400490: PCT Rod, Curved, 3.5x45mm, Ti 6Al-4V
• 00840283400483: PCT Rod, Curved, 3.5x40mm, Ti 6Al-4V
• 00840283400476: PCT Rod, Curved, 3.5x35mm, Ti 6Al-4V
• 00840283400469: PCT Rod, Curved, 3.5x30mm, Ti 6Al-4V
• 00840283400452: PCT Rod, Curved, 3.5x25mm, Ti 6Al-4V
• 00840283400445: PCT Lamina Hook, Long, Right, Ti 6Al-4V
• 00840283400438: PCT Lamina Hook, Long, Left, Ti 6Al-4V
• 00840283400421: PCT Lamina Hook, Short, Left, Ti 6Al-4V
• 00840283400414: PCT Lamina Hook, Short, Right, Ti 6Al-4V
• 00840283400407: Set Screw, Ti 6Al-4V