FDA device listing
Awl,Awl/Tapper,Drill Bit,Drill Guide,Dual Pitch Awl/Tapper,Fixone Instrument,Genesis AWL,Genesis AWL/Tapper,Genesis…
FDA device listing 1540589055 · AJU Medical Co., Ltd.
Key facts
| Proprietary names | Awl,Awl/Tapper,Drill Bit,Drill Guide,Dual Pitch Awl/Tapper,Fixone Instrument,Genesis AWL,Genesis AWL/Tapper,Genesis Drill Bit,Genesis Drill Guide,Genesis Dual Pitch AWL/Tapper |
|---|---|
| Owner/operator | AJU Medical Co., Ltd. |
| Owner/operator number | 10056622 |
| 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 | Aju Medical Co., Ltd. |
| Establishment registrations | 3014232239 |
| FEI numbers | 3014232239 |
| Establishment operations | 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