| Primary Device ID | 07290117350874 |
| NIH Device Record Key | dbffc8d8-4e18-44f0-8de1-b0ffaa1fa18a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CarboClear X Pedicle Screw System |
| Version Model Number | MIS Distractor/Compressor |
| Catalog Number | MIS021 |
| 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 |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290117350874 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
[07290117350874]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-21 |
| Device Publish Date | 2023-09-13 |
| 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) |