FDA device listing
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
FDA device listing 1935627807 · Zimmer Biomet APAC DFE
Key facts
| Owner/operator | Zimmer Biomet APAC DFE |
|---|---|
| Owner/operator number | 10056128 |
| Premarket submissions | K984296 |
| Product codes | JDI, LPH |
| Device names | JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3350, 888.3358 |
| Review panels | Orthopedic |
| Registered establishments | Zimmer Biomet Korea Ltd., Zimmer Biomet Pty Ltd, Zimmer Biomet Taiwan Co., Ltd., ZIMMER PTE. LTD., Zimmer (Shanghai) Medical International Trading Co., Ltd. |
| Establishment registrations | 3011683674, 3013176080, 3015207155, 3015542154, 3035366890 |
| FEI numbers | 3011683674, 3013176080, 3015207155, 3015542154, 3035366890 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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