Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K210716
CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments · CarboFix Orthopedics , Ltd. · decided 2021-04-06 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CarboClear X Pedicle Screw System | Pedicle Screw - Fenestrated | CARBOFIX ORTHOPEDICS LTD | NKB PML | 07290117350416 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Non Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110206765 |
| 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 | 07290110206802 |
| 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 | 07290110206710 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290117351932 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290117350492 |
| CarboClear X Pedicle Screw System | Navigated Screwdriver Adaptor | CARBOFIX ORTHOPEDICS LTD | NKB OLO | 07290117350058 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Fenestrated | CARBOFIX ORTHOPEDICS LTD | NKB PML | 07290117350270 |
| CarboClear X Pedicle Screw System | Set Screw Starter | CARBOFIX ORTHOPEDICS LTD | NKB | 07290117350041 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Non Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110206819 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Non Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110206703 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290117350539 |
| CarboClear X Pedicle Screw System | Set Screw Locker | CARBOFIX ORTHOPEDICS LTD | NKB | 07290117350010 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110209872 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Fenestrated | CARBOFIX ORTHOPEDICS LTD | NKB PML | 07290117350317 |
| CarboClear X Pedicle Screw System | Rod Reducer | CARBOFIX ORTHOPEDICS LTD | NKB | 07290117350003 |
| CarboClear X Pedicle Screw System | Rod Pusher | CARBOFIX ORTHOPEDICS LTD | NKB | 07290109339078 |
| CarboClear X Pedicle Screw System | Sterilization Case | CARBOFIX ORTHOPEDICS LTD | NKB OLO | 07290110209964 |
| CarboClear X Pedicle Screw System | Locking Element - Set Screw | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110207373 |
| CarboClear X Pedicle Screw System | Screw Block | CARBOFIX ORTHOPEDICS LTD | NKB OLO | 07290117354759 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Non Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110206741 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Non Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110206796 |
| CarboClear X Pedicle Screw System | Pedicle Screw - Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290117350508 |