Idys®- C ZP 3DTi 44063512-S

GUDID 03700780644018

SCREW

CLARIANCE

Metallic spinal interbody fusion cage

• Primary Device ID: 03700780644018
• NIH Device Record Key: e389a835-1c8c-4fc1-9ada-feaf15c559a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idys®- C ZP 3DTi
• Version Model Number: 44063512-S
• Catalog Number: 44063512-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: false
• 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: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780644018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240715

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

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: 2024-04-04
• Device Publish Date: 2024-03-27

On-Brand Devices [Idys®- C ZP 3DTi]

• 03700780644001: GIMBAL
• 03700780643837: ANGULATED PUNCH RETRACTABLE
• 03700780643820: RETRACTABLE PUNCH
• 03700780644216: SCREW
• 03700780644209: SCREW
• 03700780644193: SCREW
• 03700780644186: SCREW
• 03700780644049: SCREW
• 03700780644032: SCREW
• 03700780644025: SCREW
• 03700780644018: SCREW