Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K103497
CERAMIC FEMORAL HEAD · United Orthopedic Corp. · decided 2011-03-04 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| U2™ Hip | 1403-6452 | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872168478 |
| U2 U-Motion Acetabular Component | 1203-2232 | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872179016 |
| U2 U-Motion Acetabular Component | 1203-2432 | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872179030 |
| U-Motion II™ | 1203-6240-RB | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872159964 |
| U2 U-Motion Acetabular Component | 1203-2428-RA | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872167853 |
| Ceramic Femoral Head BIOLOX® Delta 12/14M | 1203-5228 | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04712771494921 |
| U-Motion II | 1203-6432-RC | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04711605586740 |
| U-Motion II™ | 1203-6632-RA | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872160069 |
| Ceramic Femoral Head BIOLOX® Delta 12/14L | 1203-5432 | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04712771494952 |
| U-Motion II | 1203-6428-RC | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04711605586733 |
| U-Motion II™ | 1203-6240-RA | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872159957 |
| Ceramic Femoral Head BIOLOX® Delta 12/14L | 1203-5428 | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04712771494945 |
| U2™ Hip | 1403-6460 | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872168515 |
| U-Motion II | 1203-6028-RC | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04711605586658 |
| U2 U-Motion Acetabular Component | 1203-2432-RA | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872167860 |
| U-Motion II | 1203-6228-RB | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872159902 |
| U-Motion II™ | 1203-6036-RA | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872159858 |
| Ceramic Femoral Head BIOLOX® Forte 12/14L | 1203-1432 | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04712602341653 |
| U2 U-Motion Acetabular Component | 1203-2028-RA | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872167792 |
| U2 U-Motion Acetabular Component | 1203-2032 | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872178996 |
| U-Motion II™ | 1203-6228-RA | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872159896 |
| U-Motion II™ | 1203-6440-RA | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872160038 |
| U-Motion II™ | 1203-6432-RB | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872160007 |
| U2 U-Motion Acetabular Component | 1203-2232-RA | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872167839 |
| U-Motion II™ | 1203-6436-RB | UNITED ORTHOPEDIC CORP. | LPH LWJ MEH | 04719872160021 |