Idys®-ALIF 24020540-S

GUDID 03700780634446

2x Vertebral screw

CLARIANCE

Metallic spinal interbody fusion cage

• Primary Device ID: 03700780634446
• NIH Device Record Key: a3c42853-0924-4637-92a6-331bacf9dc66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idys®-ALIF
• Version Model Number: 24020540-S
• Catalog Number: 24020540-S
• Company DUNS: 296568400
• Company Name: CLARIANCE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us

Device Dimensions

• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780634446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202032

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-16
• Device Publish Date: 2021-04-08

On-Brand Devices [Idys®-ALIF]

• 03700780634477: 2x Vertebral screw
• 03700780634460: 2x Vertebral screw
• 03700780634453: 2x Vertebral screw
• 03700780634446: 2x Vertebral screw
• 03700780634439: 2x Vertebral screw