Idys®- C ZP 3DTi 44063518-S

GUDID 03700780644025

SCREW

CLARIANCE

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 03700780644025
• NIH Device Record Key: d9340045-06a9-4e94-b854-8c41c6891a17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idys®- C ZP 3DTi
• Version Model Number: 44063518-S
• Catalog Number: 44063518-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: 18 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 18 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 18 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 18 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 18 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 18 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 18 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 18 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 18 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 18 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 18 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 18 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 18 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 18 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 18 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 18 Millimeter
• Outer Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780644025 [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