United Orthopedic Corporation
FDA 510(k) & PMA Approved Devices — 26 products
Total Devices26
Categories9
Latest FDA decision2025-09-25
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K252725 | Stem Extension Line (U2 Total Knee System—PSA Type) | JWH | 2025-09-25 | View |
| 510(k) | K252303 | Stem Extension Line (USTAR II System) | KRO | 2025-08-22 | View |
| 510(k) | K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | MBH | 2025-07-31 | View |
| 510(k) | K242315 | Resolve Modular Revision Hip Stem | MEH | 2025-05-01 | View |
| 510(k) | K243466 | Conformity Stem Extension Line, #0 | LZO | 2025-01-06 | View |
| 510(k) | K243024 | Cellbrick Knee Spacer | JWH | 2024-12-20 | View |
| 510(k) | K242249 | Conformity Stem Extension Line | LZO | 2024-08-30 | View |
| 510(k) | K221705 | U2 Total Knee System-PF+ | MBH | 2023-02-28 | View |
| 510(k) | K221149 | U-Motion II Acetabular System-Extension line | LZO | 2023-01-05 | View |
| 510(k) | K221675 | United U2 femoral head, 22mm delta ceramic head | LPH | 2022-11-04 | View |
| 510(k) | K222700 | Tibial baseplate, Tibial insert | JWH | 2022-10-06 | View |
| 510(k) | K210961 | U2 Total Knee System, XPE Tibial Insert, PS PLUS | JWH | 2021-04-21 | View |
| 510(k) | K191056 | Conformity stem, cemented | JDI | 2020-01-03 | View |
| 510(k) | K190100 | USTAR II System | KRO | 2019-09-23 | View |
| 510(k) | K183312 | Conformity Stem | LZO | 2019-08-08 | View |
| 510(k) | K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | OQI | 2018-06-12 | View |
| 510(k) | K172251 | UTS Stem | LPH | 2017-10-24 | View |
| 510(k) | K170089 | U-Motion II Acetabular System— Additional sizes | LZO | 2017-10-06 | View |
| 510(k) | K163441 | Locking Cage, Full XPE Cup | LZO | 2017-08-25 | View |
| 510(k) | K162957 | U2 Femoral Head | LPH | 2017-07-17 | View |
No matching devices.
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