CarboClear Cervical Systems PL940103

GUDID 07290117351277

Screwdriver for use with the CarboClear cervical systems

CARBOFIX ORTHOPEDICS LTD

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

• 07290110206550 - CarboClear Lumbar Cage System: 2024-09-11 A surgical tool used for the introduction of the CarboClear Lumbar Cage into the disc space.
• 07290110206567 - CarboClear Lumbar Cage System: 2024-09-11 A surgical tool used for the introduction of the CarboClear Lumbar Cage into the disc space.
• 07290117350812 - CarboClear X Pedicle Screw System: 2024-09-11 Part of the CarboClear X Pedicle Screw System - MIS Supplemental Set.
• 17290117354619 - CarboClear Posterior Cervical Screw System: 2024-09-05 Posterior cervical screw
• 17290117354626 - CarboClear Posterior Cervical Screw System: 2024-09-05 Posterior cervical screw
• 07290117354636 - CarboClear Posterior Cervical Screw System: 2024-09-05 Posterior cervical screw
• 17290117354640 - CarboClear Posterior Cervical Screw System: 2024-09-05 Posterior cervical screw
• 17290117354657 - CarboClear Posterior Cervical Screw System: 2024-09-05 Posterior cervical screw