CarboClear Hybrid Pedicle Screw System HYB5535

GUDID 17290117352318

Hybrid Pedicle Screw

CARBOFIX ORTHOPEDICS LTD

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 17290117352318
• NIH Device Record Key: 494d6024-937a-4cdc-8b55-18879f5ca3be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboClear Hybrid Pedicle Screw System
• Version Model Number: Pedicle Screw
• Catalog Number: HYB5535
• 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
• 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 Dimensions

• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290117352311 [Primary]
GS1	17290117352318 [Package]; Contains: 07290117352311; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240846

FDA Product Code

• PML: Bone Cement, Posterior Screw Augmentation

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: 2024-07-23
• Device Publish Date: 2024-07-15

On-Brand Devices [CarboClear Hybrid Pedicle Screw System]

• 17290117353544: Set Screw for use as part of the CarboClear Hybrid Pedicle Screw System
• 17290117352714: Fenestrated Hybrid Pedicle Screw (oncology)
• 17290117352707: Fenestrated Hybrid Pedicle Screw (oncology)
• 17290117352691: Fenestrated Hybrid Pedicle Screw (oncology)
• 17290117352684: Fenestrated Hybrid Pedicle Screw (oncology)
• 17290117352677: Fenestrated Hybrid Pedicle Screw (oncology)
• 17290117352660: Fenestrated Hybrid Pedicle Screw (oncology)
• 17290117352653: Fenestrated Hybrid Pedicle Screw (oncology)
• 17290117352646: Fenestrated Hybrid Pedicle Screw (oncology)
• 17290117352639: Fenestrated Hybrid Pedicle Screw (oncology)
• 17290117352622: Fenestrated Hybrid Pedicle Screw (oncology)
• 17290117352615: Fenestrated Hybrid Pedicle Screw (oncology)
• 17290117352608: Fenestrated Hybrid Pedicle Screw (oncology)
• 17290117352592: Fenestrated Hybrid Pedicle Screw (oncology)
• 17290117352585: Fenestrated Hybrid Pedicle Screw (oncology)
• 17290117352578: Cannulated Hybrid Pedicle Screw
• 17290117352561: Cannulated Hybrid Pedicle Screw
• 17290117352554: Cannulated Hybrid Pedicle Screw
• 17290117352547: Cannulated Hybrid Pedicle Screw
• 17290117352530: Cannulated Hybrid Pedicle Screw
• 17290117352523: Cannulated Hybrid Pedicle Screw
• 17290117352516: Cannulated Hybrid Pedicle Screw
• 17290117352509: Cannulated Hybrid Pedicle Screw
• 17290117352493: Cannulated Hybrid Pedicle Screw
• 17290117352486: Cannulated Hybrid Pedicle Screw
• 17290117352479: Cannulated Hybrid Pedicle Screw
• 17290117352462: Cannulated Hybrid Pedicle Screw
• 17290117352455: Cannulated Hybrid Pedicle Screw
• 17290117352448: Cannulated Hybrid Pedicle Screw
• 17290117352257: Hybrid Pedicle Screw
• 17290117352240: Hybrid Pedicle Screw
• 07290117353776: Screw block holder for Hybrid Pedicle Screw
• 07290117353745: Instrument for removing Extended Tabs of MIS Hybrid Pedicle Screw
• 07290117353721: Bone surface reamer for use with the CarboClear Hybrid Pedicle Screw System
• 07290117353592: Pedicle Screw Navigated Screwdriver for use with the CarboClear Hybrid Pedicle Screw System.
• 17290117352431: Hybrid Pedicle Screw
• 17290117352424: Hybrid Pedicle Screw
• 17290117352417: Hybrid Pedicle Screw
• 17290117352400: Hybrid Pedicle Screw
• 17290117352394: Hybrid Pedicle Screw
• 17290117352387: Hybrid Pedicle Screw
• 17290117352370: Hybrid Pedicle Screw
• 17290117352363: Hybrid Pedicle Screw
• 17290117352356: Hybrid Pedicle Screw
• 17290117352349: Hybrid Pedicle Screw
• 17290117352332: Hybrid Pedicle Screw
• 17290117352325: Hybrid Pedicle Screw
• 17290117352318: Hybrid Pedicle Screw
• 17290117352301: Hybrid Pedicle Screw
• 17290117352295: Hybrid Pedicle Screw