| Primary Device ID | 07290110204730 |
| NIH Device Record Key | fb7f1be0-a9e1-44d7-b4fa-8f02c24a5e59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CarboClear Pedicle Screw System |
| Version Model Number | Distractor |
| Catalog Number | PPS922450 |
| 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 | |
| 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 | 07290110204730 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
[07290110204730]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-23 |
| Device Publish Date | 2018-07-23 |
| 07290110205041 | Gauge for use with the CarboClear Pedicle Screw System trans-connectors. |
| 07290110205034 | Wrench for use with the CarboClear Pedicle Screw System trans-connectors unlocker. |
| 07290110205027 | Unlocker for use with the CarboClear Pedicle Screw System trans-connectors. |
| 07290110205010 | Locking Device for use with the CarboClear Pedicle Screw System trans-connectors. |
| 17290110204874 | Curved Rod (oncology) of the CarboClear Pedicle Screw System |
| 17290110204867 | Curved Rod (oncology) of the CarboClear Pedicle Screw System |
| 17290110204850 | Curved Rod (oncology) of the CarboClear Pedicle Screw System |
| 17290110204843 | Curved Rod (oncology) of the CarboClear Pedicle Screw System |
| 17290110204836 | Curved Rod (oncology) of the CarboClear Pedicle Screw System |
| 17290110204829 | Straight Rod (oncology) of the CarboClear Pedicle Screw System |
| 17290110204812 | Straight Rod (oncology) of the CarboClear Pedicle Screw System |
| 17290110204805 | Straight Rod (oncology) of the CarboClear Pedicle Screw System |
| 17290110204799 | Straight Rod (oncology) of the CarboClear Pedicle Screw System |
| 07290110204785 | Straight Rod (oncology) of the CarboClear Pedicle Screw System |
| 07290110204778 | Rod cutting instruments for use with the CarboClear Pedicle Screw System. |
| 07290110204761 | Non cannulated pedicle screw (oncology) |
| 17290110204751 | Non cannulated pedicle screw (oncology) |
| 07290110204747 | Mallet for use with the CarboClear Pedicle Screw System. |
| 07290110204730 | Distraction device for use with the CarboClear Pedicle Screw System. |
| 07290110204723 | Rod End Shaper for use with the CarboClear Pedicle Screw System. |
| 07290110204716 | Saw for use with the CarboClear Pedicle Screw System. |
| 07290110204709 | Compression device for use with the CarboClear Pedicle Screw System. |
| 07290110204693 | Pedicle Screw Extractor for use with the CarboClear Pedicle Screw System. |
| 07290110204686 | Pedicle Screw Extractor for use with the CarboClear Pedicle Screw System. |
| 07290110204679 | Pedicle Screw Extractor for use with the CarboClear Pedicle Screw System. |
| 07290110204662 | Unlocker for use with the CarboClear Pedicle Screw System. |
| 07290110204655 | Locking Element positioning device for use with the CarboClear Pedicle Screw System. |
| 07290110204648 | Unlocker for use with the CarboClear Pedicle Screw System. |
| 07290110204631 | Sterilization case for use with the CarboClear Pedicle Screw System. |
| 07290110204624 | Container for use with the CarboClear Pedicle Screw System. |
| 07290110202200 | Iliac Crest Rod of the CarboClear Pedicle Screw System |
| 07290110202002 | Template for use with the CarboClear Pedicle Screw System. |
| 07290110201982 | Template for use with the CarboClear Pedicle Screw System. |
| 07290110201975 | Template for use with the CarboClear Pedicle Screw System. |
| 07290110201968 | Template for use with the CarboClear Pedicle Screw System. |
| 17290110201958 | Trans-Connector Locking Element (and Ring) for use as part of the CarboClear Pedicle Screw Syste |
| 17290110201941 | Trans-Connector Rod of the CarboClear Pedicle Screw System |
| 17290110201934 | Trans-Connector Rod of the CarboClear Pedicle Screw System |
| 17290110201927 | Trans-Connector Rod of the CarboClear Pedicle Screw System |
| 17290110201910 | Trans-Connector Rod of the CarboClear Pedicle Screw System |
| 17290110201903 | Trans-Connector Rod of the CarboClear Pedicle Screw System |
| 17290110201897 | Trans-Connector Rod of the CarboClear Pedicle Screw System |
| 17290110201880 | Trans-Connector Rod of the CarboClear Pedicle Screw System |
| 17290110201873 | Trans-Connector Rod of the CarboClear Pedicle Screw System |
| 17290110201866 | Trans-Connector Rod of the CarboClear Pedicle Screw System |
| 17290110201859 | Trans-Connector Rod of the CarboClear Pedicle Screw System |
| 17290110201842 | Trans-Connector Rod of the CarboClear Pedicle Screw System |
| 17290110201835 | Trans-Connector Rod of the CarboClear Pedicle Screw System |
| 17290110201828 | Trans-Connector Rod of the CarboClear Pedicle Screw System |
| 17290110201811 | Trans-Connector Rod of the CarboClear Pedicle Screw System |