Idys® TLIF 06533311

GUDID 03700780613465

TLIF CAGE

CLARIANCE

Polymeric spinal interbody fusion cage

• Primary Device ID: 03700780613465
• NIH Device Record Key: 53911d36-47e6-488e-8ccb-19d7c07b279b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idys® TLIF
• Version Model Number: 06533311
• Catalog Number: 06533311
• 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
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us

Device Dimensions

• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter
• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter
• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter
• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter
• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter
• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter
• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter
• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter
• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter
• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter
• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter
• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter
• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter
• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter
• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter
• Height: 8 Millimeter
• Depth: 28 Millimeter
• Width: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780613465 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243670

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, 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: 2025-02-03
• Device Publish Date: 2025-01-24

On-Brand Devices [Idys® TLIF]

• 03700780613519: TLIF CAGE
• 03700780613502: TLIF CAGE
• 03700780613496: TLIF CAGE
• 03700780613489: TLIF CAGE
• 03700780613472: TLIF CAGE
• 03700780613465: TLIF CAGE
• 03700780613458: TLIF CAGE
• 03700780613441: TLIF CAGE
• 03700780613434: TLIF CAGE
• 03700780613427: TLIF CAGE
• 03700780602803: TLIF CAGE
• 03700780602797: TLIF CAGE
• 03700780602780: TLIF CAGE
• 03700780602773: TLIF CAGE
• 03700780602766: TLIF CAGE
• 03700780602759: TLIF CAGE
• 03700780602742: TLIF CAGE
• 03700780602735: TLIF CAGE