FDA device listing
12.5mm Tap,135 Degree Angle Guide,140 Degree Angle Guide,145 Degree Angle Guide,2.4mm Cannulated Screws and Instruments…
FDA device listing 1676326492 · Microware Precision Co., Ltd.
Key facts
| Proprietary names | 12.5mm Tap,135 Degree Angle Guide,140 Degree Angle Guide,145 Degree Angle Guide,2.4mm Cannulated Screws and Instruments Case,3.5mm Hexdriver Shaft (Short),3.5mm Wood Handle Screwdriver,4.0mm Cannulate Screws and Instruments Case,4.5mm Tap,7.3 CANNULATED SCREW AND INSTRUMENT SET,Centering Sleeve for Lag Screw Wrench,Centering Sleeve for Tap,Countersink, Cannulated, 7.3mm Cannulated… |
|---|---|
| Owner/operator | Microware Precision Co., Ltd. |
| Owner/operator number | 10028733 |
| 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 | MICROWARE PRECISION CO., LTD. |
| Establishment registrations | 3007738812 |
| FEI numbers | 3007738812 |
| 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