Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K103733
UNITED U2 XPE TOTAL KNEE SYSTEM · United Orthopedic Corporation · decided 2011-08-02 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| XPE Tibial Insert, CR | 2303-1653 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484397 |
| XPE Tibial Insert, CR | 2303-1645 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484366 |
| XPE Tibial Insert, PS | 2303-3622 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484533 |
| XPE Patellar, On set, 3 pegs | 2403-3210 | UNITED ORTHOPEDIC CORP. | JWH | 04712771485264 |
| XPE Tibial Insert, CR | 2303-1665 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484465 |
| XPE Patellar, On set, 3 pegs | 2403-3250 | UNITED ORTHOPEDIC CORP. | JWH | 04712771485301 |
| XPE Tibial Insert, PS | 2303-3655 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484717 |
| XPE Tibial Insert, PS | 2303-3623 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484540 |
| XPE Patella | 2403-3010 | UNITED ORTHOPEDIC CORP. | JWH | 04712771485226 |
| XPE Tibial Insert, PS | 2303-3614 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484502 |
| U2 Total Knee System | 2303-1632 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484281 |
| XPE Patellar, On set, 3 pegs | 2403-3220 | UNITED ORTHOPEDIC CORP. | JWH | 04712771485271 |
| XPE Tibial Insert, CR | 2303-1654 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484403 |
| XPE Patella | 2403-3020 | UNITED ORTHOPEDIC CORP. | JWH | 04712771485233 |
| XPE Tibial Insert, PS | 2303-3665 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484762 |
| XPE Tibial Insert, PS | 2303-3613 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484496 |
| XPE Patellar, On set, 3 pegs | 2403-3240 | UNITED ORTHOPEDIC CORP. | JWH | 04712771485295 |
| XPE Tibial Insert, PS | 2303-3663 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484748 |
| XPE Tibial Insert, PS | 2303-3642 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484632 |
| U2 Total Knee System | 2303-1631 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484274 |
| XPE Patellar, On set, 3 pegs | 2403-3260 | UNITED ORTHOPEDIC CORP. | JWH | 04712771485318 |
| XPE Tibial Insert, PS | 2303-3652 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484687 |
| U2 Total Knee System | 2303-1615 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484212 |
| XPE Tibial Insert, PS | 2303-3662 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484731 |
| U2 Total Knee System | 2303-1622 | UNITED ORTHOPEDIC CORP. | JWH | 04712771484236 |