FDA device listing
hedrocel trabecular metal vertebral body replacement, mod
FDA device listing 2019840478 · ZIMMER, INC.
Key facts
| Proprietary names | hedrocel trabecular metal vertebral body replacement, mod |
|---|---|
| Owner/operator | ZIMMER, INC. |
| Owner/operator number | 1822565 |
| Premarket submissions | K031823 |
| Product codes | MQP |
| Device names | MQP - Spinal Vertebral Body Replacement Device |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3060 |
| Review panels | Orthopedic |
| Registered establishments | Zimmer Trabecular Metal Technology, Inc. |
| Establishment registrations | 3005751028 |
| FEI numbers | 3005751028 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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