Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K211742
SignaSure Dual Mobility System · Signature Orthopaedics Pty, Ltd. · decided 2022-01-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SignaSure Cup Backing Plate | 112-35-0764 | SIGNATURE ORTHOPAEDICS PTY LTD | LXH | 09348215084882 |
| SignaSure Poly | 111-27-0247 | SIGNATURE ORTHOPAEDICS PTY LTD | LZO MEH | 09348215031343 |
| SignaSure Trial Poly | 112-35-0250 | SIGNATURE ORTHOPAEDICS PTY LTD | HWT | 09348215080013 |
| SignaSure Poly | 111-27-0253 | SIGNATURE ORTHOPAEDICS PTY LTD | LZO MEH | 09348215031374 |
| SignaSure Main Instrument Tray | 112-35-0000 | SIGNATURE ORTHOPAEDICS PTY LTD | KCT | 09348215084899 |
| SignaSure Cup Backing Plate | 112-35-0752 | SIGNATURE ORTHOPAEDICS PTY LTD | LXH | 09348215084820 |
| SignaSure Trial Poly | 112-35-0256 | SIGNATURE ORTHOPAEDICS PTY LTD | HWT | 09348215080051 |
| SignaSure Cup Backing Plate | 112-35-0760 | SIGNATURE ORTHOPAEDICS PTY LTD | LXH | 09348215084868 |
| SignaSure Poly | 111-27-0239 | SIGNATURE ORTHOPAEDICS PTY LTD | LZO MEH | 09348215031299 |
| Femoral Trial Head | 112-35-0007 | SIGNATURE ORTHOPAEDICS PTY LTD | HWT | 09348215098919 |
| SignaSure Trial Shell | 112-35-0454 | SIGNATURE ORTHOPAEDICS PTY LTD | HWT | 09348215084523 |
| SignaSure Cemented Cup | 111-27-0656 | SIGNATURE ORTHOPAEDICS PTY LTD | LZO | 09348215031190 |
| SignaSure Cemented Cup | 111-27-0664 | SIGNATURE ORTHOPAEDICS PTY LTD | LZO | 09348215031237 |
| SignaSure Poly | 111-27-0257 | SIGNATURE ORTHOPAEDICS PTY LTD | LZO MEH | 09348215031398 |
| SignaSure Cemented Cup | 111-27-0660 | SIGNATURE ORTHOPAEDICS PTY LTD | LZO | 09348215031213 |
| SignaSure Cementless Cup | 111-27-0158 | SIGNATURE ORTHOPAEDICS PTY LTD | LZO MEH | 09348215031084 |
| SignaSure Cemented Cup | 111-27-0654 | SIGNATURE ORTHOPAEDICS PTY LTD | LZO | 09348215031183 |
| SignaSure Cementless Cup | 111-27-0162 | SIGNATURE ORTHOPAEDICS PTY LTD | LZO MEH | 09348215031107 |
| Logical Dual Mobility Poly Insert | 01-042-02-2841 | SIGNATURE ORTHOPAEDICS PTY LTD | LZO MEH | 09348215112448 |
| SignaSure Poly | 111-27-0205 | SIGNATURE ORTHOPAEDICS PTY LTD | LZO MEH | 09348215083472 |
| SignaSure Cemented Cup | 111-27-0646 | SIGNATURE ORTHOPAEDICS PTY LTD | LZO | 09348215031145 |
| SignaSure Trial Shell | 112-35-0446 | SIGNATURE ORTHOPAEDICS PTY LTD | HWT | 09348215084486 |
| SignaSure Cemented Cup | 111-27-0658 | SIGNATURE ORTHOPAEDICS PTY LTD | LZO | 09348215031206 |
| SignaSure Cup Backing Plate | 112-35-0756 | SIGNATURE ORTHOPAEDICS PTY LTD | LXH | 09348215084844 |
| SignaSure Trial Shell | 112-35-0456 | SIGNATURE ORTHOPAEDICS PTY LTD | HWT | 09348215084530 |