Idys™ TLIF 3DTi Cages 31573315-S

GUDID 03700780625734

Intervertebral cage

CLARIANCE

Metallic spinal interbody fusion cage

• Primary Device ID: 03700780625734
• NIH Device Record Key: 9f31bd94-8f10-424a-9a87-86045b1fa105
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idys™ TLIF 3DTi Cages
• Version Model Number: 31573315-S
• Catalog Number: 31573315-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: 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: 7738687041
• Email: s.chambat@clariance-spine.us

Device Dimensions

• Height: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780625734 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172465

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-12-29

On-Brand Devices [Idys™ TLIF 3DTi Cages]

• 03700780625758: Intervertebral cage
• 03700780625734: Intervertebral cage
• 03700780625710: Intervertebral cage
• 03700780625697: Intervertebral cage
• 03700780625673: Intervertebral cage
• 03700780625659: Intervertebral cage
• 03700780625635: Intervertebral cage
• 03700780625611: Intervertebral cage
• 03700780625598: Intervertebral cage
• 03700780625574: Intervertebral cage
• 03700780625550: Intervertebral cage
• 03700780625543: Intervertebral cage
• 03700780625536: Intervertebral cage
• 03700780625529: Intervertebral cage
• 03700780625512: Intervertebral cage
• 03700780625505: Intervertebral cage
• 03700780625499: Intervertebral cage
• 03700780625482: Intervertebral cage