Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K113789
MODULAR PROXIMALLY FLUTED HIP STEM · Smith & Nephew, Inc. · decided 2012-04-19 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| (unnamed) | 71354176 | Smith & Nephew, Inc. | LZO | 00885556024287 |
| REDAPT | 71354174 | Smith & Nephew, Inc. | LZO | 00885556022948 |
| (unnamed) | 71360094 | Smith & Nephew, Inc. | LZO | 03596010619327 |
| REDAPT | 71354340 | Smith & Nephew, Inc. | LZO | 00885556211793 |
| REDAPT | 71354323 | Smith & Nephew, Inc. | LZO | 00885556210949 |
| REDAPT | 71355092 | Smith & Nephew, Inc. | LZO | 00885556222997 |
| REDAPT | 71354149 | Smith & Nephew, Inc. | LZO | 00885556023822 |
| REDAPT | 71354337 | Smith & Nephew, Inc. | LZO | 00885556211649 |
| POLAR | E0016520-1 | Smith & Nephew, Inc. | LZO | 00885556754436 |
| PLUS | E0017042-1 | Smith & Nephew, Inc. | LZO | 00885556789414 |
| REDAPT | 71354312 | Smith & Nephew, Inc. | LZO | 00885556210390 |
| Anthology | E0017278-1 | Smith & Nephew, Inc. | LZO | 00885556804629 |
| REDAPT | 71354335 | Smith & Nephew, Inc. | LZO | 00885556211540 |
| REDAPT | 71354327 | Smith & Nephew, Inc. | LZO | 00885556211144 |
| SMF | 71360083 | Smith & Nephew, Inc. | LZO | 03596010619273 |
| REDAPT | 71354319 | Smith & Nephew, Inc. | LZO | 00885556210741 |
| Anthology | 71365721 | Smith & Nephew, Inc. | LZO | 03596010553409 |
| (unnamed) | 71354178 | Smith & Nephew, Inc. | LZO | 00885556022795 |
| POLAR | E0016935-1 | Smith & Nephew, Inc. | LZO | 00885556780824 |
| EMPERION | 71360917 | Smith & Nephew, Inc. | LZO | 03596010535221 |
| REDAPT | 71354325 | Smith & Nephew, Inc. | LZO | 00885556211045 |
| REDAPT | 71354338 | Smith & Nephew, Inc. | LZO | 00885556211694 |
| Anthology | E0017278-2 | Smith & Nephew, Inc. | LZO | 00885556804636 |
| REDAPT | 71355084 | Smith & Nephew, Inc. | LZO | 00885556222645 |
| SMF | 71360084 | Smith & Nephew, Inc. | LZO | 03596010619280 |