Idys® PTLIF 04522814

GUDID 03700780601813

PTLIF CAGE

CLARIANCE

Polymeric spinal interbody fusion cage

• Primary Device ID: 03700780601813
• NIH Device Record Key: 3e2084f6-25ca-42a1-9123-13a9fb847f2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idys® PTLIF
• Version Model Number: 04522814
• Catalog Number: 04522814
• 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	03700780601813 [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® PTLIF]

• 03700780601882: PTLIF CAGE
• 03700780601875: PTLIF CAGE
• 03700780601868: PTLIF CAGE
• 03700780601851: PTLIF CAGE
• 03700780601844: PTLIF CAGE
• 03700780601837: PTLIF CAGE
• 03700780601820: PTLIF CAGE
• 03700780601813: PTLIF CAGE
• 03700780601806: PTLIF CAGE
• 03700780601790: PTLIF CAGE
• 03700780601783: PTLIF CAGE
• 03700780601776: PTLIF CAGE
• 03700780601769: PTLIF CAGE
• 03700780601752: PTLIF CAGE