VyPlate™

GUDID 00840283401954

Single-Level Plate, 16mm, Ti 6Al-4V

VY SPINE LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840283401954
• NIH Device Record Key: 6c600923-ba82-45b6-8a31-e707e3f29075
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VyPlate™
• Version Model Number: 06-P1-16-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840283401954 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221572

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840283401954]

Moist Heat or Steam Sterilization

[00840283401954]

Moist Heat or Steam Sterilization

[00840283401954]

Moist Heat or Steam Sterilization

[00840283401954]

Moist Heat or Steam Sterilization

[00840283401954]

Moist Heat or Steam Sterilization

[00840283401954]

Moist Heat or Steam Sterilization

[00840283401954]

Moist Heat or Steam Sterilization

[00840283401954]

Moist Heat or Steam Sterilization

[00840283401954]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-29
• Device Publish Date: 2025-09-26

On-Brand Devices [VyPlate™]

• 00840283402081: Two-Level Plate, 52mm, Ti 6Al-4V
• 00840283402067: Two-Level Plate, 44mm, Ti 6Al-4V
• 00840283402050: Two-Level Plate, 40mm, Ti 6Al-4V
• 00840283402043: Two-Level Plate, 36mm, Ti 6Al-4V
• 00840283402036: Two-Level Plate, 32mm, Ti 6Al-4V
• 00840283402012: Two-Level Plate, 24mm, Ti 6Al-4V
• 00840283402005: Single-Level Plate, 26mm, Ti 6Al-4V
• 00840283401978: Single-Level Plate, 20mm, Ti 6Al-4V
• 00840283401961: Single-Level Plate, 18mm, Ti 6Al-4V
• 00840283401954: Single-Level Plate, 16mm, Ti 6Al-4V
• 00840283401725: Drilling, Variable Screw, Ø4.0x12mm, Ti 6Al-4V
• 00840283405839: Single-Level Plate, 10mm, Ti 6Al-4V
• 00840283401664: Threaded Fixation Pin