Idys®-ALIF 3DTi 46573410-S

GUDID 03700780631438

Cage ALIF 3DTi

CLARIANCE

Metallic spinal interbody fusion cage

• Primary Device ID: 03700780631438
• NIH Device Record Key: 2973d9f6-8830-4a6b-a6cb-293f64a1ec8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idys®-ALIF 3DTi
• Version Model Number: 46573410-S
• Catalog Number: 46573410-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

• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter
• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter
• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter
• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter
• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter
• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter
• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter
• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter
• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter
• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter
• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter
• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter
• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter
• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter
• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter
• Angle: 10 degree
• Height: 14 Millimeter
• Depth: 30 Millimeter
• Width: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780631438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200919

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: 2021-07-13
• Device Publish Date: 2021-07-05

On-Brand Devices [Idys®-ALIF 3DTi]

• 03700780631506: Cage ALIF 3DTi
• 03700780631490: Cage ALIF 3DTi
• 03700780631483: Cage ALIF 3DTi
• 03700780631476: Cage ALIF 3DTi
• 03700780631469: Cage ALIF 3DTi
• 03700780631452: Cage ALIF 3DTi
• 03700780631445: Cage ALIF 3DTi
• 03700780631438: Cage ALIF 3DTi
• 03700780631421: Cage ALIF 3DTi
• 03700780631414: Cage ALIF 3DTi
• 03700780631407: Cage ALIF 3DTi
• 03700780631391: Cage ALIF 3DTi
• 03700780631384: Cage ALIF 3DTi
• 03700780631377: Cage ALIF 3DTi
• 03700780631360: Cage ALIF 3DTi
• 03700780631353: Cage ALIF 3DTi
• 03700780631346: Cage ALIF 3DTi
• 03700780631339: Cage ALIF 3DTi
• 03700780631322: Cage ALIF 3DTi
• 03700780631315: Cage ALIF 3DTi
• 03700780631308: Cage ALIF 3DTi
• 03700780631292: Cage ALIF 3DTi
• 03700780631285: Cage ALIF 3DTi
• 03700780631278: Cage ALIF 3DTi
• 03700780631261: Cage ALIF 3DTi
• 03700780631254: Cage ALIF 3DTi
• 03700780631247: Cage ALIF 3DTi
• 03700780631230: Cage ALIF 3DTi
• 03700780631223: Cage ALIF 3DTi
• 03700780631216: Cage ALIF 3DTi
• 03700780631209: Cage ALIF 3DTi
• 03700780631193: Cage ALIF 3DTi
• 03700780631186: Cage ALIF 3DTi
• 03700780631179: Cage ALIF 3DTi
• 03700780631162: Cage ALIF 3DTi
• 03700780631155: Cage ALIF 3DTi
• 03700780631148: Cage ALIF 3DTi
• 03700780631131: Cage ALIF 3DTi
• 03700780631124: Cage ALIF 3DTi
• 03700780631117: Cage ALIF 3DTi
• 03700780631100: Cage ALIF 3DTi
• 03700780631094: Cage ALIF 3DTi
• 03700780631087: Cage ALIF 3DTi
• 03700780631070: Cage ALIF 3DTi
• 03700780631063: Cage ALIF 3DTi
• 03700780631056: Cage ALIF 3DTi
• 03700780631049: Cage ALIF 3DTi
• 03700780631032: Cage ALIF 3DTi
• 03700780631025: Cage ALIF 3DTi
• 03700780631018: Cage ALIF 3DTi