Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K173487
CarboClear® Pedicle Screw System · CarboFix Orthopedics , Ltd. · decided 2018-07-18 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CarboClear Pedicle Screw System | Template - Rod Type 3 | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110201982 |
| CarboClear Pedicle Screw System | Pedicle Screw - Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110204969 |
| CarboClear Pedicle Screw System | Pedicle Screw - Non Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110200718 |
| CarboClear Pedicle Screw System | Tap | CARBOFIX ORTHOPEDICS LTD | NKB | 07290109338934 |
| CarboClear Pedicle Screw System | Rachet T-Handle | CARBOFIX ORTHOPEDICS LTD | NKB | 07290109338910 |
| CarboClear Pedicle Screw System | Probe - Blunt, Straight | CARBOFIX ORTHOPEDICS LTD | NKB | 07290109338842 |
| CarboClear Pedicle Screw System | Pedicle Screw - Non Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110200671 |
| CarboClear Pedicle Screw System | Holding Forceps | CARBOFIX ORTHOPEDICS LTD | NKB | 07290109339016 |
| CarboClear Pedicle Screw System | Spreader | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110205768 |
| CarboClear Pedicle Screw System | Extractor | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110204679 |
| CarboClear Pedicle Screw System | Rod - Type 4 | CARBOFIX ORTHOPEDICS LTD | NKB | 07290109336367 |
| CarboClear Pedicle Screw System | Rod - Type 1 | CARBOFIX ORTHOPEDICS LTD | NKB | 07290109336336 |
| CarboClear Pedicle Screw System | Patient Specific Curved Rod | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110208233 |
| CarboClear Pedicle Screw System | Straight Rod | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110204785 |
| CarboClear Pedicle Screw System | Unlocker - One Piece | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110204648 |
| CarboClear Pedicle Screw System | Sterilization Case | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110204631 |
| CarboClear Pedicle Screw System | Rod - Type 5 | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110200763 |
| CarboClear Pedicle Screw System | Pedicle Screw - Non Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110204761 |
| CarboClear Pedicle Screw System | Rod - Type 2 | CARBOFIX ORTHOPEDICS LTD | NKB | 07290109336343 |
| CarboClear Pedicle Screw System | Pedicle Screw - Non Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110201616 |
| CarboClear Pedicle Screw System | Extractor | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110204693 |
| CarboClear Pedicle Screw System | Pedicle Screw - Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110206260 |
| Piccolo Composite Nailing System / CarboClear Pedicle Screw System | Mallet | CARBOFIX ORTHOPEDICS LTD | HSB NKB | 07290109338002 |
| CarboClear Pedicle Screw System | Straight Rod | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110204815 |
| CarboClear Pedicle Screw System | Pedicle Screw - Non Cannulated | CARBOFIX ORTHOPEDICS LTD | NKB | 07290110200640 |