ClariVy™

GUDID 00840283400261

IBF Trial, 14x11, 5mm

VY SPINE LLC

Spinal implant trial

• Primary Device ID: 00840283400261
• NIH Device Record Key: 36138a24-0852-40de-ba49-b2f1ed76aaad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClariVy™
• Version Model Number: 02-IT-1411-05
• 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
• Phone: 866-489-7746
• Email: info@vyspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840283400261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212715

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

[00840283400261]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-22
• Device Publish Date: 2024-08-14

On-Brand Devices [ClariVy™]

• 00840283400179: IBF Rasp
• 00840283400162: IBF Inserter
• 00840283400155: IBF, Sterile, 14x11, 7°, 10mm, PEEK Optima LT1-HA
• 00840283400148: IBF, Sterile, 14x11, 7°, 9mm, PEEK Optima LT1-HA
• 00840283400131: IBF, Sterile, 14x11, 7°, 8mm, PEEK Optima LT1-HA
• 00840283400124: IBF, Sterile, 14x11, 7°, 7mm, PEEK Optima LT1-HA
• 00840283400117: IBF, Sterile, 14x11, 7°, 6mm, PEEK Optima LT1-HA
• 00840283400100: IBF, Sterile, 14x11, 7°, 5mm, PEEK Optima LT1-HA
• 00840283400094: IBF, Sterile, 14x11, 7°, 4mm, PEEK Optima LT1-HA
• 00840283400230: IBF Trial, 12x10, 8mm
• 00840283400223: IBF Trial, 12x10, 7mm
• 00840283400216: IBF Trial, 12x10, 6mm
• 00840283400209: IBF Trial, 12x10, 5mm
• 00840283400193: IBF Trial, 12x10, 4mm
• 00840283400247: IBF Trial, 12x10, 9mm
• 00840283400087: IBF, Sterile, 14x11, 0°, 10mm, PEEK Optima LT1-HA
• 00840283400070: IBF, Sterile, 14x11, 0°, 9mm, PEEK Optima LT1-HA
• 00840283400063: IBF, Sterile, 14x11, 0°, 8mm, PEEK Optima LT1-HA
• 00840283400056: IBF, Sterile, 14x11, 0°, 7mm, PEEK Optima LT1-HA
• 00840283400049: IBF, Sterile, 14x11, 0°, 6mm, PEEK Optima LT1-HA
• 00840283400032: IBF, Sterile, 14x11, 0°, 5mm, PEEK Optima LT1-HA
• 00840283400025: IBF, Sterile, 14x11, 0°, 4mm, PEEK Optima LT1-HA
• 00840283400278: IBF Trial, 14x11, 6mm
• 00840283400261: IBF Trial, 14x11, 5mm
• 00840283400254: IBF Trial, 14x11, 4mm
• 00840283400292: IBF Trial, 14x11, 8mm
• 00840283400285: IBF Trial, 14x11, 7mm
• 00840283400308: IBF Trial, 14x11, 9mm
• 00840283405259: OsteoVy™ PEKK IBF, Sterile, 12x10, 7°, 8mm, OXPEKK IG100
• 00840283405242: OsteoVy™ PEKK IBF, Sterile, 12x10, 7°, 7mm, OXPEKK IG100
• 00840283401237: IBF Trial, 14x11 / 16x14