TiWave C Cervical Cage System

GUDID B07320CFX64120

Cervical Cage, Flat, 16x14, 12mm, 14 degree Extra Tapered

Kalitec Direct LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: B07320CFX64120
• NIH Device Record Key: 917b23dc-2c72-42ac-bddc-694885d5338e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiWave C Cervical Cage System
• Version Model Number: 20-CFX-6412
• 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	B07320CFX64120 [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 ]

• B07320TAX64080: Cervical Trial, Anatomic, 16x14, 8mm, 14 degree Extra Tapered
• B07320TAT64100: Cervical Trial, Anatomic, 16x14, 10mm, 7 degree Tapered
• B07320TAT64080: Cervical Trial, Anatomic, 16x14, 8mm, 7 degree Tapered
• B07320CFX73110: Cervical Cage, Flat, 17x13, 11mm, 14 degree Extra-Tapered
• B07320CFX73090: Cervical Cage, Flat, 17x13, 9mm, 14 degree Extra-Tapered
• B07320CFX64120: Cervical Cage, Flat, 16x14, 12mm, 14 degree Extra Tapered
• B07320CFX64110: Cervical Cage, Flat, 16x14, 11mm, 14 degree Extra Tapered
• B07320CFX64100: Cervical Cage, Flat, 16x14, 10mm, 14 degree Extra Tapered
• B07320CFX64080: Cervical Cage, Flat, 16x14, 8mm, 14 degree Extra Tapered
• B07320CFX64070: Cervical Cage, Flat, 16x14, 7mm, 14 degree Extra Tapered
• B07320CFX64060: Cervical Cage, Flat, 16x14, 6mm, 14 degree Extra Tapered
• B07320CFT73090: Cervical Cage, Flat, 17x13, 9mm, 7 degree Tapered
• B07320CFT73080: Cervical Cage, Flat, 17x13, 8mm, 7 degree Tapered
• B07320CFT73050: Cervical Cage, Flat, 17x13, 5mm, 7 degree Tapered
• B07320CFT64120: Cervical Cage, Flat, 16x14, 12mm, 7 degree Tapered
• B07320CFT64110: Cervical Cage, Flat, 16x14, 11mm, 7 degree Tapered
• B07320CFT64100: Cervical Cage, Flat, 16x14, 10mm, 7 degree Tapered
• B07320CFT64090: Cervical Cage, Flat, 16x14, 9mm, 7 degree Tapered
• B07320CFT64080: Cervical Cage, Flat, 16x14, 8mm, 7 degree Tapered
• B07320CFT64070: Cervical Cage, Flat, 16x14, 7mm, 7 degree Tapered
• B07320CFT64060: Cervical Cage, Flat, 16x14, 6mm, 7 degree Tapered
• B07320CFT64050: Cervical Cage, Flat, 16x14, 5mm, 7 degree Tapered
• B07320CFN73060: Cervical Cage, Flat, 17x13, 6mm, 0 degree Non-Tapered
• B07320CFN73050: Cervical Cage, Flat, 17x13, 5mm, 0 degree Non-Tapered
• B07320CFN64120: Cervical Cage, Flat, 16x14, 12mm, 0 degree Non-Tapered
• B07320CFN64110: Cervical Cage, Flat, 16x14, 11mm, 0 degree Non-Tapered
• B07320CFN64100: Cervical Cage, Flat, 16x14, 10mm, 0 degree Non-Tapered
• B07320CFN64090: Cervical Cage, Flat, 16x14, 9mm, 0 degree Non-Tapered
• B07320CFN64070: Cervical Cage, Flat, 16x14, 7mm, 0 degree Non-Tapered
• B07320CFN64060: Cervical Cage, Flat, 16x14, 6mm, 0 degree Non-Tapered
• B07320CFN64050: Cervical Cage, Flat, 16x14, 5mm, 0 degree Non-Tapered
• B07320CFN52100: Cervical Cage, Flat, 15x12, 10mm, 0 degree Non-Tapered
• B07320CAX73100: Cervical Cage, Anatomic, 17x13, 10mm, 14 degree Extra-Tapered
• B07320CAX73090: Cervical Cage, Anatomic, 17x13, 9mm, 14 degree Extra-Tapered
• B07320CAX73070: Cervical Cage, Anatomic, 17x13, 7mm, 14 degree Extra-Tapered
• B07320CAX73060: Cervical Cage, Anatomic, 17x13, 6mm, 14 degree Extra-Tapered
• B07320CAX64110: Cervical Cage, Anatomic, 16x14, 11mm, 14 degree Extra Tapered
• B07320CAX64100: Cervical Cage, Anatomic, 16x14, 10mm, 14 degree Extra Tapered
• B07320CAX64070: Cervical Cage, Anatomic, 16x14, 7mm, 14 degree Extra Tapered
• B07320CAX64060: Cervical Cage, Anatomic, 16x14, 6mm, 14 degree Extra Tapered
• B07320CAT73110: Cervical Cage, Anatomic, 17x13, 11mm, 7 degree Tapered
• B07320CAT73100: Cervical Cage, Anatomic, 17x13, 10mm, 7 degree Tapered
• B07320CAT73090: Cervical Cage, Anatomic, 17x13, 9mm, 7 degree Tapered
• B07320CAT73080: Cervical Cage, Anatomic, 17x13, 8mm, 7 degree Tapered
• B07320CAT73070: Cervical Cage, Anatomic, 17x13, 7mm, 7 degree Tapered
• B07320CAT73060: Cervical Cage, Anatomic, 17x13, 6mm, 7 degree Tapered
• B07320CAT73050: Cervical Cage, Anatomic, 17x13, 5mm, 7 degree Tapered
• B07320CAT64120: Cervical Cage, Anatomic, 16x14, 12mm, 7 degree Tapered
• B07320CAT64110: Cervical Cage, Anatomic, 16x14, 11mm, 7 degree Tapered
• B07320CAT64050: Cervical Cage, Anatomic, 16x14, 5mm, 7 degree Tapered