FDA device listing
MALLET, SURGICAL, GENERAL & PLASTIC SURGERY
FDA device listing 1302567432 · ORTHOFIX SRL
Key facts
| Proprietary names | MALLET, SURGICAL, GENERAL & PLASTIC SURGERY |
|---|---|
| Owner/operator | ORTHOFIX SRL |
| Owner/operator number | 9011783 |
| Product codes | GFJ |
| Device names | GFJ - Mallet, Surgical, General & Plastic Surgery |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | ORTHOFIX SRL |
| Establishment registrations | 9680825 |
| FEI numbers | 3002807827 |
| Establishment operations | 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