FDA device listing
5020 Console; 5025 Console
FDA device listing 1547135991 · Pivot - EDM
Key facts
| Proprietary names | 5020 Console; 5025 Console |
|---|---|
| Owner/operator | Pivot - EDM |
| Owner/operator number | 10061153 |
| Product codes | HWE |
| Device names | HWE - Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4820 |
| Review panels | General & Plastic Surgery |
| Registered establishments | PIVOT - EDM |
| Establishment registrations | 3014903258 |
| FEI numbers | 3014903258 |
| Establishment operations | Contract Manufacturer |
| 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