Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K193378
CarboClear Lumbar Cage System · CarboFix Orthopedics , Ltd. · decided 2020-03-02 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CarboClear Lumbar Cage System | Shaver – 11 mm | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206451 |
| CarboClear Lumbar Cage System | Sterilization Box | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206635 |
| CarboClear Lumbar Cage System | Implant Trial-10x23x10mm | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206857 |
| CarboClear Lumbar Cage System | T-Handle | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206499 |
| CarboClear Lumbar Cage System | Cage Inserter – Inner Rod M3 | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110208684 |
| CarboClear Lumbar Cage System | Cubic Cage | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206543 |
| CarboClear Lumbar Cage System | Cage Inserter – Inner Rod | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206567 |
| CarboClear Lumbar Cage System | Implant Trial-10x23x14mm | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206871 |
| CarboClear Lumbar Cage System | Slap Graft Hammer | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206574 |
| CarboClear Lumbar Cage System | Cubic Cage | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206666 |
| CarboClear Lumbar Cage System | Cubic Cage | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206529 |
| CarboClear Lumbar Cage System | Implant Trial-10x23x12mm | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206864 |
| CarboClear Lumbar Cage System | Shaver – 13 mm | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206475 |
| CarboClear Lumbar Cage System | Cubic Cage | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206642 |
| CarboClear Lumbar Cage System | Shaver – 8 mm | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206420 |
| CarboClear Lumbar Cage System | Shaver – 12 mm | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206468 |
| CarboClear Lumbar Cage System | Cubic Cage | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206536 |
| CarboClear Lumbar Cage System | Bone Funnel | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206611 |
| CarboClear Lumbar Cage System | Shaver – 10 mm | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206444 |
| CarboClear Lumbar Cage System | Cubic Cage | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206659 |
| CarboClear Lumbar Cage System | Implant Trial-10x27x8mm | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206888 |
| CarboClear Lumbar Cage System | Bone Graft Tamp | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206628 |
| CarboClear Lumbar Cage System | Implant Trial-10x23x8mm | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206840 |
| CarboClear Lumbar Cage System | Cubic Cage | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206505 |
| CarboClear Lumbar Cage System | Cubic Cage | CARBOFIX ORTHOPEDICS LTD | MAX | 07290110206512 |