FDA device listing
0.9mm x 100mm K-wire,1.4mm ClearnIng WIre,1.4mm x 150mm K-wIre,1.5 Case Cover,1.5mm screw case,1.6mm * 180mm K-wire,2.0…
FDA device listing 1882225127 · Double Medical Technology Inc.
Key facts
| Proprietary names | 0.9mm x 100mm K-wire,1.4mm ClearnIng WIre,1.4mm x 150mm K-wIre,1.5 Case Cover,1.5mm screw case,1.6mm * 180mm K-wire,2.0 Case Cover,2.0mm/2.4mm Locking Plate/Screw Case,2.0mm/2.4mm Locking Screw Case,2.0mm Drill Bit, Length 100mm,2.0mm Kirschner Wire, 350mm,2.0mm Kirschner Wire, with olive head, 350/200mm,2.0mm screw case,2.2mm x 250mm K-wIre,2.4/2.7/3.5mm screw rack,2.4/2.7 Screw… |
|---|---|
| Owner/operator | Double Medical Technology Inc. |
| Owner/operator number | 10045395 |
| 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 | Double Medical Technology Inc. |
| Establishment registrations | 3010440433 |
| FEI numbers | 3010440433 |
| Establishment operations | Contract Manufacturer, 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