CarboClear Vertebral Body Replacement System SP0011

GUDID 07290110209841

Patient-Specific spinal vertebral body replacement device

CARBOFIX ORTHOPEDICS LTD

Vertebral body prosthesis

• Primary Device ID: 07290110209841
• NIH Device Record Key: 64d0df09-8c98-4c71-92c5-362642c518bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboClear Vertebral Body Replacement System
• Version Model Number: Patient Specific VBR Spacer
• Catalog Number: SP0011
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110209841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192214

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

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: 2021-05-21
• Device Publish Date: 2021-05-13

On-Brand Devices [CarboClear Vertebral Body Replacement System]

• 07290110205782: A spinal vertebral body replacement device
• 07290110206130: A spinal vertebral body replacement device
• 07290110206123: A spinal vertebral body replacement device
• 07290110206116: A spinal vertebral body replacement device
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• 07290110206062: A spinal vertebral body replacement device
• 07290110206055: A spinal vertebral body replacement device
• 07290110206048: A spinal vertebral body replacement device
• 07290110206031: A spinal vertebral body replacement device
• 07290110206024: A spinal vertebral body replacement device
• 07290110206017: A spinal vertebral body replacement device
• 07290110206000: A spinal vertebral body replacement device
• 07290110205997: A spinal vertebral body replacement device
• 07290110205980: A spinal vertebral body replacement device
• 07290110205973: A spinal vertebral body replacement device
• 07290110205966: A spinal vertebral body replacement device
• 07290110205959: A spinal vertebral body replacement device
• 07290110205942: A spinal vertebral body replacement device
• 07290110205935: A spinal vertebral body replacement device
• 07290110205928: A spinal vertebral body replacement device
• 07290110205911: A spinal vertebral body replacement device
• 07290110205904: A spinal vertebral body replacement device
• 07290110205898: A spinal vertebral body replacement device
• 07290110205881: A spinal vertebral body replacement device
• 07290110205874: A spinal vertebral body replacement device
• 07290110205867: A spinal vertebral body replacement device
• 07290110205850: A spinal vertebral body replacement device
• 07290110205843: A spinal vertebral body replacement device
• 07290110205836: A spinal vertebral body replacement device
• 07290110205829: A spinal vertebral body replacement device
• 07290110205812: A spinal vertebral body replacement device
• 07290110205805: A spinal vertebral body replacement device
• 07290110205799: A spinal vertebral body replacement device
• 07290110206147: Handle for use with the CarboClear VBR (vertebral body replacement) System
• 07290110209841: Patient-Specific spinal vertebral body replacement device