Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K093363
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS · Smith & Nephew, Inc. · decided 2010-01-26 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| R3 | 71338709 | Smith & Nephew, Inc. | MBL | 00885556112991 |
| R3 | 71338688 | Smith & Nephew, Inc. | MBL | 00885556113172 |
| R3 | 71338698 | Smith & Nephew, Inc. | MBL | 00885556113080 |
| R3 | 71331110 | Smith & Nephew, Inc. | MBL | 03596010651983 |
| R3 | 71338679 | Smith & Nephew, Inc. | MBL | 00885556113257 |
| R3 | 71331119 | Smith & Nephew, Inc. | MBL | 00885556113479 |
| R3 | 71338706 | Smith & Nephew, Inc. | MBL | 00885556113028 |
| (unnamed) | 71344248 | Smith & Nephew, Inc. | MBL | 00885556022962 |
| R3 | 71338689 | Smith & Nephew, Inc. | MBL | 00885556113165 |
| R3 | 71338690 | Smith & Nephew, Inc. | MBL | 00885556113158 |
| OXINIUM | 71342344 | Smith & Nephew, Inc. | MBL | 03596010652003 |
| R3 | 71331111 | Smith & Nephew, Inc. | MBL | 03596010651990 |
| R3 | 71338687 | Smith & Nephew, Inc. | MBL | 00885556113189 |
| R3 | 71338697 | Smith & Nephew, Inc. | MBL | 00885556113097 |
| R3 | 71331121 | Smith & Nephew, Inc. | MBL | 00885556113462 |
| R3 | 71331106 | Smith & Nephew, Inc. | MBL | 03596010651945 |
| R3 | 71338692 | Smith & Nephew, Inc. | MBL | 00885556113134 |
| R3 | 71338708 | Smith & Nephew, Inc. | MBL | 00885556113004 |
| R3 | 71338695 | Smith & Nephew, Inc. | MBL | 00885556113110 |
| OXINIUM | 71342340 | Smith & Nephew, Inc. | MBL | 00885556112410 |
| R3 | 71331109 | Smith & Nephew, Inc. | MBL | 03596010651976 |
| R3 | 71330014 | Smith & Nephew, Inc. | MBL | 03596010651921 |
| R3 | 71338696 | Smith & Nephew, Inc. | MBL | 00885556113103 |
| (unnamed) | 71342640 | Smith & Nephew, Inc. | MBL | 00885556022603 |
| R3 | 71331107 | Smith & Nephew, Inc. | MBL | 03596010651952 |