CarboClear X Pedicle Screw System XDT5545

GUDID 17290117355159

CarboClear X Dual Thread Pedicle Screw Solid

CARBOFIX ORTHOPEDICS LTD

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 17290117355159
• NIH Device Record Key: 992c45a6-1461-4ce9-a7cf-92e2255720f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboClear X Pedicle Screw System
• Version Model Number: Pedicle Screw - Dual Thread
• Catalog Number: XDT5545
• 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

Device Dimensions

• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290117355152 [Primary]
GS1	17290117355159 [Package]; Contains: 07290117355152; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231280

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-14
• Device Publish Date: 2025-04-06

On-Brand Devices [CarboClear X Pedicle Screw System]

• 17290110209947: Cannulated pedicle screw
• 17290110209930: Cannulated pedicle screw
• 17290110209923: Cannulated pedicle screw
• 17290110209916: Cannulated pedicle screw
• 17290110209909: Cannulated pedicle screw
• 17290110209893: Cannulated pedicle screw
• 17290110209886: Cannulated pedicle screw
• 07290110209872: Cannulated pedicle screw
• 17290110209831: Non-cannulated pedicle screw
• 17290110209824: Non-cannulated pedicle screw
• 17290110209817: Non-cannulated pedicle screw
• 17290110209800: Non-cannulated pedicle screw
• 17290110209794: Non-cannulated pedicle screw
• 17290110209787: Non-cannulated pedicle screw
• 17290110207370: Locking Element (Set Screw) for use as part of the CarboClear X Pedicle Screw System
• 17290110206830: Non-cannulated pedicle screw
• 17290110206823: Non-cannulated pedicle screw
• 17290110206816: Non-cannulated pedicle screw
• 17290110206809: Non-cannulated pedicle screw
• 17290110206793: Non-cannulated pedicle screw
• 17290110206786: Non-cannulated pedicle screw
• 17290110206779: Non-cannulated pedicle screw
• 17290110206762: Non-cannulated pedicle screw
• 17290110206755: Non-cannulated pedicle screw
• 17290110206748: Non-cannulated pedicle screw
• 17290110206731: Non-cannulated pedicle screw
• 17290110206724: Non-cannulated pedicle screw
• 17290110206717: Non-cannulated pedicle screw
• 17290110206700: Non-cannulated pedicle screw
• 07290117350065: Pedicle Screw Navigated Screwdriver for use with the CarboClear X Pedicle Screw System.
• 07290117350058: An adaptor for the Pedicle Screw Navigated Screwdriver for use with the CarboClear X Pedicle Scr
• 07290117350041: Set Screw Starter for use with the CarboClear X Pedicle Screw System.
• 07290117350034: Handle for use with the Rod Reducer of the CarboClear X Pedicle Screw System.
• 07290117350027: Counter-torque for use with the CarboClear X Pedicle Screw System.
• 07290117350010: Set Screw Locker for use with the CarboClear X Pedicle Screw System.
• 07290117350003: Tulip Adjuster for use with the CarboClear X Pedicle Screw System.
• 07290110209995: Tulip Adjuster for use with the CarboClear X Pedicle Screw System.
• 07290110209971: Pedicle Screw Screwdriver for use with the CarboClear X Pedicle Screw System.
• 07290110209964: Sterilization case for use with the CarboClear X Pedicle Screw System.
• 17290117350444: Fenestrated pedicle screw (oncology)
• 17290117350437: Fenestrated pedicle screw (oncology)
• 17290117350420: Fenestrated pedicle screw (oncology)
• 17290117350413: Fenestrated pedicle screw (oncology)
• 17290117350406: Fenestrated pedicle screw (oncology)
• 17290117350390: Fenestrated pedicle screw (oncology)
• 17290117350383: Fenestrated pedicle screw (oncology)
• 17290117350376: Fenestrated pedicle screw (oncology)
• 17290117350369: Fenestrated pedicle screw (oncology)
• 17290117350352: Fenestrated pedicle screw (oncology)
• 17290117350345: Fenestrated pedicle screw (oncology)