tIwave c caervical Cage System

GUDID B07320CFX94070

Cervical Cage, flat, 19mm x 14mm, 7mm, 14 degrees, extra tapered

Kalitec Direct LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: B07320CFX94070
• NIH Device Record Key: 82753913-5c2e-4a24-ae65-9cb7330a168b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: tIwave c caervical Cage System
• Version Model Number: 20-CFX-9407
• Company DUNS: 041956211
• Company Name: Kalitec Direct LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B07320CFX94070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180401

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-08-31

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