FDA device listing
Surgical Instrument
FDA device listing 1668979650 · Corin Group
Key facts
| Proprietary names | Surgical Instrument |
|---|---|
| Owner/operator | Corin Group |
| Owner/operator number | 9012268 |
| Product codes | LXH |
| Device names | LXH - Orthopedic Manual Surgical Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | Corin Limited, OPTIMIZED ORTHO PTY LTD |
| Establishment registrations | 9614209, 3012916784 |
| FEI numbers | 3002806725, 3012916784 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer, 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