Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K221675
United U2 femoral head, 22mm delta ceramic head · United Orthopedic Corporation · decided 2022-11-04 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Ceramic Femoral Head | 1203-5022 | UNITED ORTHOPEDIC CORP. | KWY LPH | 04719886890822 |
| Ceramic Femoral Head | 1203-5422 | UNITED ORTHOPEDIC CORP. | KWY LPH | 04719886890846 |
| U-Motion II | 1203-6422-RB | UNITED ORTHOPEDIC CORP. | KWY LPH | 04719886901139 |
| U-Motion II | 1203-6022-RC | UNITED ORTHOPEDIC CORP. | KWY LPH | 04719886891171 |
| U-Motion II | 1203-6422-RC | UNITED ORTHOPEDIC CORP. | KWY LPH | 04719886891195 |
| U-Motion II | 1203-6222-RB | UNITED ORTHOPEDIC CORP. | KWY LPH | 04719886901122 |
| U-Motion II | 1203-6022-RB | UNITED ORTHOPEDIC CORP. | KWY LPH | 04719886901115 |
| Ceramic Femoral Head | 1203-5222 | UNITED ORTHOPEDIC CORP. | KWY LPH | 04719886890839 |
| U-Motion II | 1203-6222-RC | UNITED ORTHOPEDIC CORP. | KWY LPH | 04719886891188 |