CarboClear Cervical VBR System CVBR14408

GUDID 07290110209261

A cervical spine vertebral body replacement device

CARBOFIX ORTHOPEDICS LTD

Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis

• Primary Device ID: 07290110209261
• NIH Device Record Key: 097472e4-a0db-44b1-b9ba-727b56cbf22f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboClear Cervical VBR System
• Version Model Number: VBR Spacer
• Catalog Number: CVBR14408
• Company DUNS: 649185170
• Company Name: CARBOFIX ORTHOPEDICS LTD
• 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: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com

Device Dimensions

• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree
• Height: 40 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 8 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110209261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222874

FDA Product Code

• PLR: Spinal Vertebral Body Replacement Device - Cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-25
• Device Publish Date: 2023-10-17

On-Brand Devices [CarboClear Cervical VBR System]

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