Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K180754
C-Zero Pedicle Screw System, Freedom Pedicle Screw System · Signature Orthopaedics Pty, Ltd. · decided 2018-12-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Centaur Pedicle Screw System | 131-08-2755 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215127114 |
| C-Zero Pedicle Screw System | 131-32-1735 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215028169 |
| Centaur Pedicle Screw System | 131-08-1630 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215126612 |
| C-Zero Pedicle Screw System | 131-32-1535 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215027988 |
| Freedom Pedicle Screw System | 131-13-7755 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215029319 |
| Centaur Pedicle Screw System | 131-08-1060 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215126452 |
| Centaur Pedicle Screw System | 131-08-0046 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215126407 |
| Freedom Pedicle Screw System | 131-13-6269 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215030537 |
| C-Zero Pedicle Screw System | 131-32-1545 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215028008 |
| Freedom Pedicle Screw System | 131-13-1735 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215027131 |
| Centaur Pedicle Screw System | 131-08-1525 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215126513 |
| Freedom Pedicle Screw System | 131-13-7530 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215029166 |
| C-Zero Pedicle Screw System | 131-32-5055 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215028862 |
| Centaur Pedicle Screw System | 131-08-2530 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215126889 |
| Freedom Pedicle Screw System | 131-13-6106 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215030438 |
| Freedom Pedicle Screw System | 131-13-3845 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215027872 |
| Centaur Pedicle Screw System | 131-08-2645 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215127008 |
| Freedom Pedicle Screw System | 131-13-9840 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215030001 |
| C-Zero Pedicle Screw System | 131-32-4855 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215028701 |
| C-Zero Pedicle Screw System | 131-32-2660 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215028398 |
| Freedom Pedicle Screw System | 131-13-2735 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215027445 |
| Freedom Pedicle Screw System | 131-13-1860 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215027285 |
| Freedom Pedicle Screw System | 131-13-8655 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215029562 |
| C-Zero Pedicle Screw System | 131-32-2560 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215028305 |
| Centaur Pedicle Screw System | 131-08-1730 | SIGNATURE ORTHOPAEDICS PTY LTD | NKB | 09348215126704 |