FDA device listing
Class I instrument
FDA device listing 1149922616 · Orthofix US LLC
Key facts
| Proprietary names | Class I instrument |
|---|---|
| Owner/operator | Orthofix US LLC |
| Owner/operator number | 10028162 |
| Product codes | HXL |
| Device names | HXL - Mallet |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | ORTHOFIX US LLC |
| Establishment registrations | 2183449 |
| FEI numbers | 2183449 |
| Establishment operations | 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