FDA device listing
1.5mm Container,2.0mm Container,2.0mm Wire Sleeve,2.4 Adjustable Drill Bit,2.4 Drill Bit, 12mm,2.4 Drill Bit, 14mm,2.4…
FDA device listing 1684432045 · Auxein Medical Pvt Ltd
Key facts
| Proprietary names | 1.5mm Container,2.0mm Container,2.0mm Wire Sleeve,2.4 Adjustable Drill Bit,2.4 Drill Bit, 12mm,2.4 Drill Bit, 14mm,2.4 Drill Bit, 16mm,2.4mm Container,2.7mm Contaitner,3.0mm Drill Bit,3.0mm Rod Holding Forceps,3.0mm Template,3.5mm Bending Template,3.5mm Cortical Tap,4.0mm Tap,4.5mm Bending Template,9mm Plate Hook Forceps,Allen Key 3.0mm,Allen Key for Dill Bit Stopper Dia3.0mm,Allen Key, Hex… |
|---|---|
| Owner/operator | Auxein Medical Pvt Ltd |
| Owner/operator number | 10046810 |
| 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 | Auxein medical Private limited |
| Establishment registrations | 3010303097 |
| FEI numbers | 3010303097 |
| Establishment operations | Complaint File Establishment, 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