FDA device listing
Osteotome, Manual
FDA device listing 1570314304 · Avalign Technologies
Key facts
| Owner/operator | Avalign Technologies |
|---|---|
| Owner/operator number | 10051835 |
| Product codes | GFI |
| Device names | GFI - Osteotome, Manual |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | AVALIGN TECHNOLOGIES, Inc., Instrumed GmbH dba Avalign German Specialty Instruments, Instrumed International Inc dba Avalign German Specialty Instruments, MILLENNIUM SURGICAL CORP |
| Establishment registrations | 1421101, 8010372, 3004215117, 3008864603 |
| FEI numbers | 1421101, 3004215117, 3007290840, 3008864603 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler, Specification Developer |
| 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