Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K200883
CarboClear® Cervical Plate System · CarboFix Orthopedics , Ltd. · decided 2020-06-04 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CarboClear Cervical Plate System | Cervical Plate 3 levels 62 mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110207045 |
| CarboClear Cervical Plate System | Self-Tapping Screw, Ø4.5mm x 10mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110207298 |
| CarboClear Cervical Systems | Screwdriver Rod - T15 | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290117351277 |
| CarboClear Cervical Plate System | Patient Specific Cervical Plate | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110208653 |
| CarboClear Cervical Plate System | Self-Tapping Screw, Ø4.5mm x 20mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110207342 |
| CarboClear Cervical Plate System | Cervical Plate 1 level 24 mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110206901 |
| CarboClear Cervical Plate System | Cervical Plate Screw Depth Gauge | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110207212 |
| CarboClear Cervical Plate System | Self-Drilling Screw, Ø4mm x 18mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110207274 |
| CarboClear Cervical Plate System | Cervical Plate Drill Bit 18mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290117353691 |
| CarboClear Cervical Systems | Cervical Systems Sterilization Case | CARBOFIX ORTHOPEDICS LTD | KWQ ODP PLR | 07290110207236 |
| CarboClear Cervical Plate System | Cervical Plate 3 levels 65 mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110207052 |
| CarboClear Cervical Plate System | Cervical Plate 1 level 26 mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110206918 |
| CarboClear Cervical Plate System | Cervical Plate 4 levels 64 mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110207076 |
| CarboClear Cervical Plate System | Cervical Plate 2 levels 41.5 mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110206970 |
| CarboClear Cervical Plate System | Cervical Plate Holder | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110207144 |
| CarboClear Cervical Plate System | Cervical Plate Awl | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110207168 |
| CarboClear Cervical Systems | Cervical Caliper | CARBOFIX ORTHOPEDICS LTD | KWQ ODP PLR | 07290110207229 |
| CarboClear Cervical Plate System | Cervical Plate Holder -Outer Part | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110208547 |
| CarboClear Cervical Plate System | Cervical Plate 2 levels 36.5 mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110206956 |
| CarboClear Cervical Plate System | Self-Tapping Screw, Ø4.5mm x 14mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110207311 |
| CarboClear Cervical Plate System | Cervical Plate Drill Bit 14mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290117353677 |
| CarboClear Cervical Plate System | Cervical Plate 1 level 28 mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110206925 |
| CarboClear Cervical Plate System | Self-Drilling Screw, Ø4mm x 20mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110207281 |
| CarboClear Cervical Plate System | Cervical Plate 3 levels 59 mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290110207038 |
| CarboClear Cervical Plate System | Cervical Plate Drill Bit 16mm | CARBOFIX ORTHOPEDICS LTD | KWQ | 07290117353684 |