CarboClear Posterior Cervical Screw System CS023

GUDID 07290117351130

Rod Reducer (Tulip Adjuster) for use with the CarboClear Posterior Cervical Screw System

CARBOFIX ORTHOPEDICS LTD

Orthopaedic counter-torque/rod-pushing instrument

• Primary Device ID: 07290117351130
• NIH Device Record Key: c5b2d789-a0cf-4b28-ba31-e3ada6c3132f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboClear Posterior Cervical Screw System
• Version Model Number: Rod Reducer
• Catalog Number: CS023
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290117351130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233989

FDA Product Code

• NKG: Posterior Cervical Screw System

Sterilization

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

[07290117351130]

Moist Heat or Steam Sterilization

[07290117351130]

Moist Heat or Steam Sterilization

[07290117351130]

Moist Heat or Steam Sterilization

[07290117351130]

Moist Heat or Steam Sterilization

[07290117351130]

Moist Heat or Steam Sterilization

[07290117351130]

Moist Heat or Steam Sterilization

[07290117351130]

Moist Heat or Steam Sterilization

[07290117351130]

Moist Heat or Steam Sterilization

[07290117351130]

Moist Heat or Steam Sterilization

[07290117351130]

Moist Heat or Steam Sterilization

[07290117351130]

Moist Heat or Steam Sterilization

[07290117351130]

Moist Heat or Steam Sterilization

[07290117351130]

Moist Heat or Steam Sterilization

[07290117351130]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-13
• Device Publish Date: 2024-06-05

On-Brand Devices [CarboClear Posterior Cervical Screw System]

• 17290117353636: Posterior cervical rod
• 17290117353629: Posterior cervical rod
• 17290117353612: Posterior cervical rod
• 07290117353585: Pedicle Screw Extractor for use with the CarboClear Posterior Cervical Screw System
• 07290117353578: Pedicle Screw Extractor for use with the CarboClear Posterior Cervical Screw System
• 07290117353561: Compression device for use with the CarboClear Posterior Cervical Screw System
• 17290117353520: Posterior cervical rod
• 17290117353513: Posterior cervical rod
• 17290117353506: Posterior cervical rod
• 17290117353490: Posterior cervical rod
• 17290117353483: Posterior cervical rod
• 17290117353476: Posterior cervical rod
• 17290117353469: Posterior cervical rod
• 17290117353452: Posterior cervical rod
• 17290117353445: Posterior cervical rod
• 17290117353438: Posterior cervical rod
• 17290117353421: Posterior cervical rod
• 17290117353414: Posterior cervical rod
• 17290117353407: Posterior cervical rod
• 17290117353391: Posterior cervical rod
• 27290117353381: Posterior cervical screw locking element (set screw)
• 17290117353377: Posterior cervical screw
• 17290117353360: Posterior cervical screw
• 17290117353353: Posterior cervical screw
• 17290117353346: Posterior cervical screw
• 17290117353339: Posterior cervical screw
• 17290117353322: Posterior cervical screw
• 17290117353315: Posterior cervical screw
• 17290117353308: Posterior cervical screw
• 17290117353292: Posterior cervical screw
• 17290117353285: Posterior cervical screw
• 17290117353278: Posterior cervical screw
• 17290117353261: Posterior cervical screw
• 17290117353254: Posterior cervical screw
• 17290117353247: Posterior cervical screw
• 17290117353230: Posterior cervical screw
• 17290117353223: Posterior cervical screw
• 07290117353219: Posterior cervical screw
• 17290117353209: Posterior cervical screw
• 07290117352212: Sterilization Box for use with the CarboClear Posterior Cervical Screw System Instrumentation Se
• 07290117351215: Saw for use with the CarboClear Posterior Cervical Screw System rods
• 07290117351208: Curved Rod Template for use with the CarboClear Posterior Cervical Screw System
• 07290117351192: Curved Rod Template for use with the CarboClear Posterior Cervical Screw System
• 07290117351185: Straight Rod Template for use with the CarboClear Posterior Cervical Screw System
• 07290117351178: Straight Rod Template for use with the CarboClear Posterior Cervical Screw System
• 07290117351154: Rod End Shaper for use with the CarboClear Posterior Cervical Screw System rods
• 07290117351147: Handle for use with the Rod Reducer of the CarboClear Posterior Cervical Screw System
• 07290117351130: Rod Reducer (Tulip Adjuster) for use with the CarboClear Posterior Cervical Screw System
• 07290117351123: Distraction device for use with the CarboClear Posterior Cervical Screw System
• 07290117351116: Part of the CarboClear Posterior Cervical Screw System Instrumentation Set.