CarboClear Cervical Plate System CERVP4600

GUDID 07290110207069

Anterior fixation cervical plate

CARBOFIX ORTHOPEDICS LTD

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 07290110207069
• NIH Device Record Key: d58ec364-1495-4293-866a-c66d5c5b1d6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboClear Cervical Plate System
• Version Model Number: Cervical Plate 4 levels 60 mm
• Catalog Number: CERVP4600
• 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

Device Dimensions

• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110207069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200883

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

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: 2023-09-18
• Device Publish Date: 2020-06-08

On-Brand Devices [CarboClear Cervical Plate System]

• 07290110207342: Self-drilling screw for use with CarboClear Cervical Plate.
• 07290110207335: Self-drilling screw for use with CarboClear Cervical Plate.
• 07290110207328: Self-drilling screw for use with CarboClear Cervical Plate.
• 07290110207311: Self-drilling screw for use with CarboClear Cervical Plate.
• 07290110207304: Self-drilling screw for use with CarboClear Cervical Plate.
• 07290110207298: Self-drilling screw for use with CarboClear Cervical Plate.
• 07290110207281: Self-drilling screw for use with CarboClear Cervical Plate.
• 07290110207274: Self-drilling screw for use with CarboClear Cervical Plate.
• 07290110207267: Self-drilling screw for use with CarboClear Cervical Plate.
• 07290110207250: Self-drilling screw for use with CarboClear Cervical Plate.
• 07290110207243: Self-drilling screw for use with CarboClear Cervical Plate.
• 07290110207236: Sterilization case for use with the CarboClear Cervical Plate System.
• 07290110207229: Intended to assist in determining the required plate length during operation.
• 07290110207212: Following screw hole preparation, where applicable, the gauge may be used to measure depth and t
• 07290110207205: Intended for locking the drill bits stopper in place.
• 07290110207199: Used to prepare the screw canal in combination with the Cervical Drill Guide.
• 07290110207182: Used to prepare the screw canal in combination with the Cervical Drill Guide.
• 07290110207175: Used to direct the drill bit to prepare the screw pathway.
• 07290110207168: Used to gain access through the bone cortex.
• 07290110207151: Used to hold the plate during screw hole preparation.
• 07290110207144: Used to securely hold the plate for proper placement and positioning.
• 07290110208554: Used to securely hold the plate for proper placement and positioning.
• 07290110208547: Used to securely hold the plate for proper placement and positioning.
• 07290110208653: Patient-Specific anterior fixation cervical plate
• 07290110207137: Anterior fixation cervical plate
• 07290110207120: Anterior fixation cervical plate
• 07290110207113: Anterior fixation cervical plate
• 07290110207106: Anterior fixation cervical plate
• 07290110207090: Anterior fixation cervical plate
• 07290110207083: Anterior fixation cervical plate
• 07290110207076: Anterior fixation cervical plate
• 07290110207069: Anterior fixation cervical plate
• 07290110207052: Anterior fixation cervical plate
• 07290110207045: Anterior fixation cervical plate
• 07290110207038: Anterior fixation cervical plate
• 07290110207021: Anterior fixation cervical plate
• 07290110207014: Anterior fixation cervical plate
• 07290110207007: Anterior fixation cervical plate
• 07290110206994: Anterior fixation cervical plate
• 07290110206987: Anterior fixation cervical plate
• 07290110206970: Anterior fixation cervical plate
• 07290110206963: Anterior fixation cervical plate
• 07290110206956: Anterior fixation cervical plate
• 07290110206949: Anterior fixation cervical plate
• 07290110206932: Anterior fixation cervical plate
• 07290110206925: Anterior fixation cervical plate
• 07290110206918: Anterior fixation cervical plate
• 07290110206901: Anterior fixation cervical plate
• 07290110206895: Anterior fixation cervical plate
• 07290117353707: Used to prepare the screw canal