Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K201278
World Hip Stem, World Cup, World Liner · Signature Orthopaedics Pty, Ltd. · decided 2020-09-21 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| World Cup Liner – High Wall | 111-49-1646 | SIGNATURE ORTHOPAEDICS PTY LTD | LPH MEH | 09348215136321 |
| World Cup Liner – Neutral Lateralised | 111-49-2346 | SIGNATURE ORTHOPAEDICS PTY LTD | KWZ LPH MEH | 09348215135393 |
| World Cup Liner – Eccentric 10 Hood Vit-E | 111-49-2950E | SIGNATURE ORTHOPAEDICS PTY LTD | LPH MEH | 09348215136963 |
| World Cup Liner – 20d Hood Lateralised | 111-49-2546 | SIGNATURE ORTHOPAEDICS PTY LTD | LPH MEH | 09348215135638 |
| World hip trial sleeve Size 0 | 112-42-1000 | SIGNATURE ORTHOPAEDICS PTY LTD | KWZ LPH MEH | 09348215065584 |
| World Cup Liner – High Wall Vit-E | 111-49-1654E | SIGNATURE ORTHOPAEDICS PTY LTD | LPH MEH | 09348215136468 |
| World Cup Liner – 10d Face Changing Vit-E | 111-49-3750E | SIGNATURE ORTHOPAEDICS PTY LTD | LPH MEH | 09348215136277 |
| World Cup Liner – 10d Face Changing Vit-E | 111-49-1746E | SIGNATURE ORTHOPAEDICS PTY LTD | LPH MEH | 09348215136208 |
| World Cup Liner – 20d Hood Lateralised | 111-49-2558 | SIGNATURE ORTHOPAEDICS PTY LTD | LPH MEH | 09348215135669 |
| World Cup Liner – 20d Hood Lateralised | 111-49-1554 | SIGNATURE ORTHOPAEDICS PTY LTD | LPH MEH | 09348215135621 |
| World Cup Size 52mm | 111-49-5052 | SIGNATURE ORTHOPAEDICS PTY LTD | KWZ LPH MEH | 09348215065072 |
| World Hip Stem Size 7L | 111-40-3723 | SIGNATURE ORTHOPAEDICS PTY LTD | KWZ LPH MEH | 09348215062392 |
| World Cup Liner – 10d Hood Lateralised | 111-49-4458 | SIGNATURE ORTHOPAEDICS PTY LTD | LPH MEH | 09348215135591 |
| World Cup Liner - 10° Hood Vit-E | 111-49-3150E | SIGNATURE ORTHOPAEDICS PTY LTD | KWZ LPH MEH | 09348215133924 |
| World Cup Trial Liner - 28C Neutral | 112-43-1013 | SIGNATURE ORTHOPAEDICS PTY LTD | KWZ LPH MEH | 09348215065645 |
| World 10° Hooded Liner Size 36D | 111-49-3158 | SIGNATURE ORTHOPAEDICS PTY LTD | KWZ LPH MEH | 09348215065355 |
| World Cup Liner – Eccentric | 111-49-1846 | SIGNATURE ORTHOPAEDICS PTY LTD | LPH MEH | 09348215136567 |
| World Cup Liner - 20° Hood Vit-E | 111-49-4254E | SIGNATURE ORTHOPAEDICS PTY LTD | KWZ LPH MEH | 09348215134075 |
| World 10° Hooded Liner Size 28C | 111-49-1154 | SIGNATURE ORTHOPAEDICS PTY LTD | KWZ LPH MEH | 09348215065287 |
| World Cup Liner - 10° Hood Vit-E | 111-49-2146E | SIGNATURE ORTHOPAEDICS PTY LTD | KWZ LPH MEH | 09348215133887 |
| World Cup Liner – High Wall Vit-E | 111-49-2650E | SIGNATURE ORTHOPAEDICS PTY LTD | LPH MEH | 09348215136482 |
| World Cup Liner – 20d Hood Lateralised | 111-49-3554 | SIGNATURE ORTHOPAEDICS PTY LTD | LPH MEH | 09348215135683 |
| World 20° Hooded Liner Size 28B | 111-49-1250 | SIGNATURE ORTHOPAEDICS PTY LTD | KWZ LPH MEH | 09348215065393 |
| World Stem Trial Size 3L | 112-42-3316 | SIGNATURE ORTHOPAEDICS PTY LTD | KWZ LPH MEH | 09348215064853 |
| World Stem Trial Size 4S | 112-42-1413 | SIGNATURE ORTHOPAEDICS PTY LTD | KWZ LPH MEH | 09348215064709 |