Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K233944
CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments · CarboFix Orthopedics , Ltd. · decided 2024-01-10 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CarboClear X Pedicle Screw System | Pedicle Screw - Non Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB OLO | 07290110209803 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Non Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB OLO | 07290110209827 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Non Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB OLO | 07290110209797 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Non Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB OLO | 07290110209834 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Non Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB OLO | 07290110209780 |