FDA device listing
Uknee Total Knee System
FDA device listing 1460326489 · UNITED ORTHOPEDIC CORPORATION
Key facts
| Proprietary names | Uknee Total Knee System |
|---|---|
| Owner/operator | UNITED ORTHOPEDIC CORPORATION |
| Owner/operator number | 9025838 |
| Premarket submissions | K021657 |
| Product codes | JWH |
| Device names | JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3560 |
| Review panels | Orthopedic |
| Registered establishments | UNITED ORTHOPEDIC CORP., UNITED ORTHOPEDIC CORPORATION, UOC USA Inc. |
| Establishment registrations | 9681642, 3009760038, 3012329926 |
| FEI numbers | 1000395711, 3009760038, 3012329926 |
| Establishment operations | Foreign Exporter, Manufacturer, U.S. Manufacturer of Export Only Devices |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database