LumiVy™

GUDID 00840283404443

Pistol Inserter

VY SPINE LLC

Internal spinal fixation procedure kit, reusable

• Primary Device ID: 00840283404443
• NIH Device Record Key: 90e47d63-fc2f-4c16-8d62-7600139cc922
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LumiVy™
• Version Model Number: 03-INP-002
• 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
• 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	00840283404443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212930

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00840283404443]

Moist Heat or Steam Sterilization

[00840283404443]

Moist Heat or Steam Sterilization

[00840283404443]

Moist Heat or Steam Sterilization

[00840283404443]

Moist Heat or Steam Sterilization

[00840283404443]

Moist Heat or Steam Sterilization

[00840283404443]

Moist Heat or Steam Sterilization

[00840283404443]

Moist Heat or Steam Sterilization

[00840283404443]

Moist Heat or Steam Sterilization

[00840283404443]

Moist Heat or Steam Sterilization

[00840283404443]

Moist Heat or Steam Sterilization

[00840283404443]

Moist Heat or Steam Sterilization

[00840283404443]

Moist Heat or Steam Sterilization

[00840283404443]

Moist Heat or Steam Sterilization

[00840283404443]

Moist Heat or Steam Sterilization

[00840283404443]

Moist Heat or Steam Sterilization

[00840283404443]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-21
• Device Publish Date: 2025-03-13

On-Brand Devices [LumiVy™]

• 00840283402487: Lumbar Rotate Cutter, 7mm
• 00840283402470: Lumbar Rotate Cutter, 6mm
• 00840283404443: Pistol Inserter
• 00840283402500: Lumbar Rotate Cutter, 9mm
• 00840283402494: Lumbar Rotate Cutter, 8mm
• 00840283402562: Lumbar Rotate Cutter, 15mm
• 00840283402555: Lumbar Rotate Cutter, 14mm
• 00840283402548: Lumbar Rotate Cutter, 13mm
• 00840283402531: Lumbar Rotate Cutter, 12mm
• 00840283402524: Lumbar Rotate Cutter, 11mm
• 00840283402517: Lumbar Rotate Cutter, 10mm
• 00840283402463: Lumbar Tamp
• 00840283402395: PLIF Trial, 10x30, 9mm
• 00840283402388: PLIF Trial, 10x30, 8mm
• 00840283402371: PLIF Trial, 10x30, 7mm
• 00840283402364: PLIF Trial, 10x30, 6mm
• 00840283402418: PLIF Trial, 10x30, 11mm
• 00840283402401: PLIF Trial, 10x30, 10mm
• 00840283402456: PLIF Trial, 10x30, 15mm
• 00840283402449: PLIF Trial, 10x30, 14mm
• 00840283402432: PLIF Trial, 10x30, 13mm
• 00840283402425: PLIF Trial, 10x30, 12mm