FDA device listing
EBI XFIX® DFS® Rail System
FDA device listing 1853543882 · LX PRECISION SHANGHAI CO LTD
Key facts
| Proprietary names | EBI XFIX® DFS® Rail System |
|---|---|
| Owner/operator | LX PRECISION SHANGHAI CO LTD |
| Owner/operator number | 10034962 |
| Product codes | KTT |
| Device names | KTT - Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030 |
| Review panels | Orthopedic |
| Registered establishments | LX PRECISION SHANGHAI CO LTD |
| Establishment registrations | 3008791302 |
| FEI numbers | 3008791302 |
| Establishment operations | Contract 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