CarboFix Orthopedics , Ltd.
FDA 510(k) & PMA Approved Devices — 25 products
Total Devices25
Categories9
Latest FDA decision2026-03-16
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System | NKG | 2026-03-16 | View |
| 510(k) | K243106 | CarboClear® Hybrid Pedicle Screw System | NKB | 2024-11-05 | View |
| 510(k) | K233793 | CarboClear® X Pedicle Screw System | NKB | 2024-08-01 | View |
| 510(k) | K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement | NKB | 2024-04-25 | View |
| 510(k) | K233989 | CarboClear® Posterior Cervical Screw System | NKG | 2024-03-27 | View |
| 510(k) | K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | NKB | 2024-01-10 | View |
| 510(k) | K232341 | CarboClear® Pedicle Screw System | NKB | 2023-10-10 | View |
| 510(k) | K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement | NKB | 2023-07-03 | View |
| 510(k) | K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments | NKB | 2021-04-06 | View |
| 510(k) | K203317 | CarboClear X Pedicle Screw System | NKB | 2020-11-25 | View |
| 510(k) | K201917 | Piccolo Composite Proximal Tibia Plate System | HRS | 2020-10-08 | View |
| 510(k) | K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System | NKB | 2020-08-07 | View |
| 510(k) | K201251 | CarboClear Navigated Instruments | OLO | 2020-08-05 | View |
| 510(k) | K200883 | CarboClear® Cervical Plate System | KWQ | 2020-06-04 | View |
| 510(k) | K200519 | CarboClear® II Pedicle Screw System | NKB | 2020-04-30 | View |
| 510(k) | K193378 | CarboClear Lumbar Cage System | MAX | 2020-03-02 | View |
| 510(k) | K192214 | CarboClear VBR System | MQP | 2019-10-11 | View |
| 510(k) | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | PML | 2019-09-19 | View |
| 510(k) | K182015 | Piccolo Composite® Plate System | HRS | 2018-10-11 | View |
| 510(k) | K182377 | CarboClear® Pedicle Screw System | NKB | 2018-09-27 | View |
No matching devices.
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