VyWasher™

GUDID 00840283400377

Screw, 4.5x30mm, Ti 6Al-4V

VY SPINE LLC

Vertebral body bone graft positioning plate

• Primary Device ID: 00840283400377
• NIH Device Record Key: 76b558bf-35dc-48d7-b97c-1abf6a4605a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VyWasher™
• Version Model Number: 12-SC-45-30-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840283400377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213219

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840283400377]

Moist Heat or Steam Sterilization

[00840283400377]

Moist Heat or Steam Sterilization

[00840283400377]

Moist Heat or Steam Sterilization

[00840283400377]

Moist Heat or Steam Sterilization

[00840283400377]

Moist Heat or Steam Sterilization

[00840283400377]

Moist Heat or Steam Sterilization

[00840283400377]

Moist Heat or Steam Sterilization

[00840283400377]

Moist Heat or Steam Sterilization

[00840283400377]

Moist Heat or Steam Sterilization

[00840283400377]

Moist Heat or Steam Sterilization

[00840283400377]

Moist Heat or Steam Sterilization

[00840283400377]

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 [VyWasher™]

• 00840283400629: Buttress System Tray
• 00840283400384: Washer, 15x20mm, Ti 6Al-4V
• 00840283400377: Screw, 4.5x30mm, Ti 6Al-4V
• 00840283400018: Screw, 4.5x25mm, Ti 6Al-4V
• 00840283400001: Staple, 15x20mm, Ti 6Al-4V