CarboClear X Pedicle Screw System PPS922460G2

GUDID 07290117350010

Set Screw Locker for use with the CarboClear X Pedicle Screw System.

CARBOFIX ORTHOPEDICS LTD

Surgical screwdriver, reusable

• Primary Device ID: 07290117350010
• NIH Device Record Key: 1be04797-4d55-4f43-bb0f-fd127e74b50e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarboClear X Pedicle Screw System
• Version Model Number: Set Screw Locker
• Catalog Number: PPS922460G2
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290117350010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210716

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[07290117350010]

Moist Heat or Steam Sterilization

[07290117350010]

Moist Heat or Steam Sterilization

[07290117350010]

Moist Heat or Steam Sterilization

[07290117350010]

Moist Heat or Steam Sterilization

[07290117350010]

Moist Heat or Steam Sterilization

[07290117350010]

Moist Heat or Steam Sterilization

[07290117350010]

Moist Heat or Steam Sterilization

[07290117350010]

Moist Heat or Steam Sterilization

[07290117350010]

Moist Heat or Steam Sterilization

[07290117350010]

Moist Heat or Steam Sterilization

[07290117350010]

Moist Heat or Steam Sterilization

[07290117350010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-08
• Device Publish Date: 2021-06-30

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)