CarboClear Cervical Cage System CC121440

GUDID 07290110209575

A cervical intervertebral fusion device

CARBOFIX ORTHOPEDICS LTD

Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 07290110209575
• NIH Device Record Key: 0fb3d709-c896-4fc0-998e-a53ae2ca4fd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboClear Cervical Cage System
• Version Model Number: Cage
• Catalog Number: CC121440
• 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: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree
• Height: 4 Millimeter
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Angle: 0 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110209575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222874

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-10
• Device Publish Date: 2023-10-02

On-Brand Devices [CarboClear Cervical Cage System]

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• 07290110209650: A cervical intervertebral fusion device
• 07290110209643: A cervical intervertebral fusion device
• 07290110209636: A cervical intervertebral fusion device
• 07290110209629: A cervical intervertebral fusion device
• 07290110209612: A cervical intervertebral fusion device
• 07290110209605: A cervical intervertebral fusion device
• 07290110209599: A cervical intervertebral fusion device
• 07290110209582: A cervical intervertebral fusion device
• 07290110209575: A cervical intervertebral fusion device