TiWAVE C Cervical Cage System

GUDID B07320CAN94050

Cervical Cage, anatomic, 19mm x 14mm, 5mm, 0 degrees, no taper

Kalitec Direct LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: B07320CAN94050
• NIH Device Record Key: 019fa10c-b480-467e-9d49-38ce934efd6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiWAVE C Cervical Cage System
• Version Model Number: 20-CAN-9405
• 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	B07320CAN94050 [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

On-Brand Devices [TiWAVE C Cervical Cage System]

• B074320CFT32090: Cervical Cage, flat, 13mm x 12mm, 9mm, 7 degrees, tapered
• B073CAN94060: Cervical Cage, anatomic, 19mm x 14mm, 6mm, 0 degrees, no taper
• B07320TFX94120: Cervical trial, flat, 19mm x 14mm, 12mm, 14 degrees, extra tapered
• B07320TFX94110: Cervical trial, flat, 19mm x 14mm, 11mm, 14 degrees, extra tapered
• B07320TFX94100: Cervical trial, flat, 19mm x 14mm, 10mm, 14 degrees, extra tapered
• B07320TFX94090: Cervical trial, flat, 19mm x 14mm, 9mm, 14 degrees, extra tapered
• B07320TFX94080: Cervical trial, flat, 19mm x 14mm, 8mm, 14 degrees, extra tapered
• B07320TFX94070: Cervical trial, flat, 19mm x 14mm, 7mm, 14 degrees, extra tapered
• B07320TFX94060: Cervical trial, flat, 19mm x 14mm, 6mm, 14 degrees, extra tapered
• B07320TFX73120: Cervical Trial, Flat, 17x13, 12mm, 14 degree Extra Tapered
• B07320TFX73110: Cervical Trial, Flat, 17x13, 11mm, 14 degree Extra Tapered
• B07320TFX73100: Cervical Trial, Flat, 17x13, 10mm, 14 degree Extra Tapered
• B07320TFX73090: Cervical Trial, Flat, 17x13, 9mm, 14 degree Extra Tapered
• B07320TFX73080: Cervical Trial, Flat, 17x13, 8mm, 14 degree Extra Tapered
• B07320TFX73070: Cervical Trial, Flat, 17x13, 7mm, 14 degree Extra Tapered
• B07320TFX73060: Cervical Trial, Flat, 17x13, 6mm, 14 degree Extra Tapered
• B07320TFX64120: Cervical Trial, Flat, 16x14, 12mm, 14 degree Extra Tapered
• B07320TFX64110: Cervical Trial, Flat, 16x14, 11mm, 14 degree Extra Tapered
• B07320TFX64100: Cervical Trial, Flat, 16x14, 10mm, 14 degree Extra Tapered
• B07320TFX64090: Cervical Trial, Flat, 16x14, 9mm, 14 degree Extra Tapered
• B07320TFX64080: Cervical Trial, Flat, 16x14, 8mm, 14 degree Extra Tapered
• B07320TFX64070: Cervical Trial, Flat, 16x14, 7mm, 14 degree Extra Tapered
• B07320TFX64060: Cervical Trial, Flat, 16x14, 6mm, 14 degree Extra Tapered
• B07320TFX52120: Cervical trial, flat, 15mm x 12mm, 12mm, 14 degree, extra tapered
• B07320TFX52110: Cervical trial, flat, 15mm x 12mm, 11mm, 14 degree, extra tapered
• B07320TFX52100: Cervical trial, flat, 15mm x 12mm, 10mm, 14 degree, extra tapered
• B07320TFX52090: Cervical trial, flat, 15mm x 12mm, 9mm, 14 degree, extra tapered
• B07320TFX52080: Cervical trial, flat, 15mm x 12mm, 8mm, 14 degree, extra tapered
• B07320TFX52070: Cervical trial, flat, 15mm x 12mm, 7mm, 14 degree, extra tapered
• B07320TFX52060: Cervical trial, flat, 15mm x 12mm, 6mm, 14 degree, extra tapered
• B07320TFX32120: Cervical trial, flat, 13mm x 12mm, 12mm, 14 degree, extra tapered
• B07320TFX32110: Cervical trial, flat, 13mm x 12mm, 11mm, 14 degree, extra tapered
• B07320TFX32100: Cervical trial, flat, 13mm x 12mm, 10mm, 14 degree, extra tapered
• B07320TFX32090: Cervical trial, flat, 13mm x 12mm, 9mm, 14 degree, extra tapered
• B07320TFX32070: Cervical trial, flat, 13mm x 12mm, 7mm, 14 degree, extra tapered
• B07320TFX32050: Cervical trial, flat, 13mm x 12mm, 5mm, 14 degree, extra tapered
• B07320TFT94120: Cervical trial, flat, 19mm x 14mm, 12mm, 7 degree, tapered
• B07320TFT94110: Cervical trial, flat, 19mm x 14mm, 11mm, 7 degree, tapered
• B07320TFT94100: Cervical trial, flat, 19mm x 14mm, 10mm, 7 degree, tapered
• B07320TFT94090: Cervical trial, flat, 19mm x 14mm, 9mm, 7 degree, tapered
• B07320TFT94080: Cervical trial, flat, 19mm x 14mm, 8mm, 7 degree, tapered
• B07320TFT94070: Cervical trial, flat, 19mm x 14mm, 7mm, 7 degree, tapered
• B07320TFT94060: Cervical trial, flat, 19mm x 14mm, 6mm, 7 degree, tapered
• B07320TFT94050: Cervical trial, flat, 19mm x 14mm, 5mm, 7 degree, tapered
• B07320TFT73120: Cervical Trial, Flat, 17x13, 12mm, 7 degree Tapered
• B07320TFT73110: Cervical Trial, Flat, 17x13, 11mm, 7 degree Tapered
• B07320TFT73100: Cervical Trial, Flat, 17x13, 10mm, 7 degree Tapered
• B07320TFT73090: Cervical Trial, Flat, 17x13, 9mm, 7 degree Tapered
• B07320TFT73080: Cervical Trial, Flat, 17x13, 8mm, 7 degree Tapered
• B07320TFT73070: Cervical Trial, Flat, 17x13, 7mm, 7 degree Tapered