Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| U2 Hip Stem | 9104-5001-RB | UNITED ORTHOPEDIC CORP. | LPH MEH | 04719872170976 |
| U2 Hip Stem | 9104-6040-RB | UNITED ORTHOPEDIC CORP. | LPH MEH | 04719872166993 |
| U2 Hip Stem, HA/Ti Plasma Spray | 1104-1024 | UNITED ORTHOPEDIC CORP. | LPH MEH | 04712602340250 |
| U2 Hip Stem | 9104-6020-RB | UNITED ORTHOPEDIC CORP. | LPH MEH | 04719872156789 |
| U2 Hip Stem, HA/Ti Plasma Spray | 1104-1034 | UNITED ORTHOPEDIC CORP. | LPH MEH | 04712602340274 |
| U2 Hip Stem | 9104-8110-RT | UNITED ORTHOPEDIC CORP. | JDI LPH MEH | 04719872177722 |
| U2 Hip Stem, HA/Ti Plasma Spray | 1104-1033 | UNITED ORTHOPEDIC CORP. | LPH MEH | 04712602340267 |
| U2 Hip Stem | 9104-6070-RA | UNITED ORTHOPEDIC CORP. | LPH MEH | 04719872167082 |
| U2 Hip Stem | 9104-6010-RA | UNITED ORTHOPEDIC CORP. | LPH MEH | 04719872166894 |
| U2 Hip Stem | 9104-8110-RA | UNITED ORTHOPEDIC CORP. | LPH MEH | 04719872146056 |
| U2 Hip Stem | 9104-6020-RA | UNITED ORTHOPEDIC CORP. | LPH MEH | 04719872166931 |
| U2 Hip Stem | 9104-6030-RA | UNITED ORTHOPEDIC CORP. | LPH MEH | 04719872166955 |
| U2 Hip Stem, HA/Ti Plasma Spray | 1104-1055 | UNITED ORTHOPEDIC CORP. | LPH MEH | 04712602340311 |
| U2 Hip Stem, Ti Porous Coated | 1104-3067 | UNITED ORTHOPEDIC CORP. | LPH MEH | 04712602340830 |
| U2 Hip Stem | 9104-6060-RA | UNITED ORTHOPEDIC CORP. | LPH MEH | 04719872167051 |
| U2 Hip Stem | 9104-6000-RA | UNITED ORTHOPEDIC CORP. | LPH MEH | 04719872166856 |
| U2 Hip Stem, HA/Ti Plasma Spray | 1104-1066 | UNITED ORTHOPEDIC CORP. | LPH MEH | 04712602340335 |
| U2 Hip Stem, HA/Ti Plasma Spray | 1104-1035 | UNITED ORTHOPEDIC CORP. | LPH MEH | 04712602340281 |
| U2 Hip Stem, HA/Ti Plasma Spray | 1104-1023 | UNITED ORTHOPEDIC CORP. | LPH MEH | 04712602340243 |
| U2 Hip Stem, HA/Ti Plasma Spray | 1104-1067 | UNITED ORTHOPEDIC CORP. | LPH MEH | 04712602340342 |
| U2 Hip Stem, Ti Porous Coated | 1104-3056 | UNITED ORTHOPEDIC CORP. | LPH MEH | 04712602340823 |
| U2 Hip Stem | 9104-6040-RA | UNITED ORTHOPEDIC CORP. | LPH MEH | 04719872166986 |
| U2 Hip Stem, Ti Porous Coated | 1104-3045 | UNITED ORTHOPEDIC CORP. | LPH MEH | 04712602340816 |
| U2 Hip Stem, Ti Porous Coated | 1104-3023 | UNITED ORTHOPEDIC CORP. | LPH MEH | 04712602340793 |
| U2 Hip Stem | 9104-6060-RB | UNITED ORTHOPEDIC CORP. | LPH MEH | 04719872167068 |