FDA device listing
1.0mm System,1.5mm System,1.5X3.5MM HT SD X-DR SCR,1.5X3.5MM X-DRIVE TF SD SCREW,1.5X4MM HT SD X-DR SCR,1.5X4MM X-DRIVE…
FDA device listing 1077806382 · LX PRECISION SHANGHAI CO LTD
Key facts
| Proprietary names | 1.0mm System,1.5mm System,1.5X3.5MM HT SD X-DR SCR,1.5X3.5MM X-DRIVE TF SD SCREW,1.5X4MM HT SD X-DR SCR,1.5X4MM X-DRIVE TF SD SCREW,1.5X5MM HT SD X-DR SCR,1.5X6MM HT SD X-DR SCR,1.5X7MM HT SD X-DR SCR,1.65X5MM HT SD X-DR SCR,1.65 X 6MM SD X-DRIVE SCREW,1.65 X 7MM HT SD X-DRIVE,2.0mm System |
|---|---|
| Owner/operator | LX PRECISION SHANGHAI CO LTD |
| Owner/operator number | 10034962 |
| Product codes | JEY |
| Device names | JEY - Plate, Bone |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.4760 |
| Review panels | Dental |
| 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