Idys™- TLIF TiVac 41533309-S

GUDID 03700780628728

TLIF cage

CLARIANCE

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 03700780628728
• NIH Device Record Key: c6723a3a-a844-453b-8e37-7b864f601bd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Idys™- TLIF TiVac
• Version Model Number: 41533309-S
• Catalog Number: 41533309-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: 7738687041
• Email: s.chambat@clariance-spine.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780628728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183259

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: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-03-06

On-Brand Devices [Idys™- TLIF TiVac]

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• 03700780628728: TLIF cage
• 03700780628711: TLIF cage
• 03700780628704: TLIF cage
• 03700780628698: TLIF cage
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• 03700780628674: TLIF cage
• 03700780628667: TLIF cage
• 03700780628650: TLIF cage
• 03700780628643: TLIF cage
• 03700780628636: TLIF cage
• 03700780628322: TLIF Cage