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

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• 07290110201715 - Piccolo Composite Plate System: 2024-12-23 Screwdriver bit (T15) for use with the Piccolo Composite Proximal Tibia Plate Systems
• 07290110208578 - Piccolo Composite Plate System: 2024-12-23 Sterilization case for use with the Piccolo Composite Proximal Tibia Plate System
• 07290117354667 - CarboClear Posterior Cervical Screw System: 2024-12-09 Posterior cervical screw
• 17290117354671 - CarboClear Posterior Cervical Screw System: 2024-12-09 Posterior cervical screw
• 17290117354688 - CarboClear Posterior Cervical Screw System: 2024-12-09 Posterior cervical screw
• 17290117354695 - CarboClear Posterior Cervical Screw System: 2024-12-09 Posterior cervical screw