FDA device listing
IPC Powerease system
FDA device listing 1427666795 · NG Instruments, Inc dba Avalign Cutting Instruments
Key facts
| Proprietary names | IPC Powerease system |
|---|---|
| Owner/operator | NG Instruments, Inc dba Avalign Cutting Instruments |
| Owner/operator number | 10042855 |
| Product codes | GWF, HBE, HWE |
| Device names | GWF - Stimulator, Electrical, Evoked Response, HBE - Drills, Burrs, Trephines & Accessories (Simple, Powered), HWE - Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 878.4820, 882.1870, 882.4310 |
| Review panels | General & Plastic Surgery, Neurology |
| Registered establishments | NGInstruments, Inc dba Avalign Cutting Instruments |
| Establishment registrations | 1835251 |
| FEI numbers | 3000205591 |
| 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