CarboClear Vertebral Body Replacement System VBRH10270

GUDID 07290110206147

Handle for use with the CarboClear VBR (vertebral body replacement) System

CARBOFIX ORTHOPEDICS LTD

Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use

• Primary Device ID: 07290110206147
• NIH Device Record Key: 7acafc02-0879-426a-a626-7a583c798938
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboClear Vertebral Body Replacement System
• Version Model Number: VBR Insertion Handle
• Catalog Number: VBRH10270
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110206147 [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: 2020-06-08
• Device Publish Date: 2020-05-31

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• 07290110206147: Handle for use with the CarboClear VBR (vertebral body replacement) System
• 07290110209841: Patient-Specific spinal vertebral body replacement device