CarboClear Cervical Systems PL940103

GUDID 07290117351277

Screwdriver for use with the CarboClear cervical systems

CARBOFIX ORTHOPEDICS LTD

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

• Primary Device ID: 07290117351277
• NIH Device Record Key: e1688b20-afa0-4b0f-9999-dce4b0352a58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboClear Cervical Systems
• Version Model Number: Screwdriver Rod - T15
• Catalog Number: PL940103
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290117351277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200883

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-26
• Device Publish Date: 2023-09-18

Devices Manufactured by CARBOFIX ORTHOPEDICS LTD

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• 07290117351376 - CarboClear Cervical VBR System: 2024-01-25 A cervical spine vertebral body replacement device
• 07290117351383 - CarboClear Cervical VBR System: 2024-01-25 A cervical spine vertebral body replacement device
• 07290117351390 - CarboClear Cervical VBR System: 2024-01-25 A cervical spine vertebral body replacement device
• 07290117351406 - CarboClear Cervical VBR System: 2024-01-25 A cervical spine vertebral body replacement device
• 17290117351915 - CarboClear X Pedicle Screw System: 2024-01-03 Cannulated pedicle screw
• 17290117351922 - CarboClear X Pedicle Screw System: 2024-01-03 Cannulated pedicle screw
• 17290117351939 - CarboClear X Pedicle Screw System: 2024-01-03 Cannulated pedicle screw