FDA device listing
Base Assembly – Lateral SI Instrument Set Base,Graft Luer Caddy Base –Lateral SI Instrument Caddy Base,Graft Luer Caddy…
FDA device listing 1610782183 · Xenix Medical
Key facts
| Proprietary names | Base Assembly – Lateral SI Instrument Set Base,Graft Luer Caddy Base –Lateral SI Instrument Caddy Base,Graft Luer Caddy Lid – Lateral SI Instrument Caddy Lid,Handle, Stealth Palm, Ratchet, TQ Limit Grey, 14 IN-LBS,Lid Assembly – Lateral SI Instrument Set Lid,Lower Assembly –Lateral SI Instrument Set Tray 2,LUX Expandable Base Tray,LUX Expandable Instrument Insert,LUX Expandable System 3.2mm Guide… |
|---|---|
| Owner/operator | Xenix Medical |
| Owner/operator number | 10051846 |
| 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 | XENIX MEDICAL |
| Establishment registrations | 3012429289 |
| FEI numbers | 3012429289 |
| Establishment operations | Complaint File Establishment, 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