FDA device listing
BIOMET CEMENT; MIXER
FDA device listing 1824881993 · Zimmer Biomet APAC DFE
Key facts
| Proprietary names | BIOMET CEMENT; MIXER |
|---|---|
| Owner/operator | Zimmer Biomet APAC DFE |
| Owner/operator number | 10056128 |
| Product codes | JDZ |
| Device names | JDZ - Mixer, Cement, For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4210 |
| Review panels | Orthopedic |
| Registered establishments | Zimmer Biomet G.K., Zimmer Biomet Korea Ltd., Zimmer Biomet Pty Ltd, Zimmer Biomet Taiwan Co., Ltd., Zimmer (Shanghai) Medical International Trading Co., Ltd. |
| Establishment registrations | 3011683674, 3012725451, 3015207155, 3015542154, 3035366890 |
| FEI numbers | 3011683674, 3012725451, 3015207155, 3015542154, 3035366890 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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