FDA device listing
DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
FDA device listing 1408513707 · Structure Medical, LLC.
Key facts
| Proprietary names | DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW |
|---|---|
| Owner/operator | Structure Medical, LLC. |
| Owner/operator number | 10042434 |
| Product codes | LXT |
| Device names | LXT - Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030 |
| Review panels | Orthopedic |
| Registered establishments | STRUCTURE MEDICAL, LLC. |
| Establishment registrations | 3006783837 |
| FEI numbers | 3009322142 |
| 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