Idys® PLIF 04522013

GUDID 03700780601677

PLIF CAGE

CLARIANCE

Polymeric spinal interbody fusion cage

• Primary Device ID: 03700780601677
• NIH Device Record Key: 2212f922-3d07-4601-a37d-276b2888b748
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idys® PLIF
• Version Model Number: 04522013
• Catalog Number: 04522013
• 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: 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: +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 Identifiers

Device Issuing Agency	Device ID
GS1	03700780601677 [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: true
• Device Is Sterile: false

[03700780601677]

Moist Heat or Steam Sterilization

[03700780601677]

Moist Heat or Steam Sterilization

[03700780601677]

Moist Heat or Steam Sterilization

[03700780601677]

Moist Heat or Steam Sterilization

[03700780601677]

Moist Heat or Steam Sterilization

[03700780601677]

Moist Heat or Steam Sterilization

[03700780601677]

Moist Heat or Steam Sterilization

[03700780601677]

Moist Heat or Steam Sterilization

[03700780601677]

Moist Heat or Steam Sterilization

[03700780601677]

Moist Heat or Steam Sterilization

[03700780601677]

Moist Heat or Steam Sterilization

[03700780601677]

Moist Heat or Steam Sterilization

[03700780601677]

Moist Heat or Steam Sterilization

[03700780601677]

Moist Heat or Steam Sterilization

[03700780601677]

Moist Heat or Steam Sterilization

[03700780601677]

Moist Heat or Steam Sterilization

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® PLIF]

• 03700780601745: PLIF CAGE
• 03700780601738: PLIF CAGE
• 03700780601721: PLIF CAGE
• 03700780601714: PLIF CAGE
• 03700780601707: PLIF CAGE
• 03700780601691: PLIF CAGE
• 03700780601684: PLIF CAGE
• 03700780601677: PLIF CAGE
• 03700780601660: PLIF CAGE
• 03700780601653: PLIF CAGE
• 03700780601646: PLIF CAGE
• 03700780601639: PLIF CAGE
• 03700780601622: PLIF CAGE