FDA device listing
ACL GUIDE,BONE AWL,BONE FILES,BONE HOLDING FORCEPS,BONE NIBBLER,BONE PUNCHES,REAMER,RONGEUR,SCREW DRIVERS,WIRE CUTTER
FDA device listing 1444155827 · STAAN BIOMED ENGINEERING PRIVATE LIMITED
Key facts
| Proprietary names | ACL GUIDE,BONE AWL,BONE FILES,BONE HOLDING FORCEPS,BONE NIBBLER,BONE PUNCHES,REAMER,RONGEUR,SCREW DRIVERS,WIRE CUTTER |
|---|---|
| Owner/operator | STAAN BIOMED ENGINEERING PRIVATE LIMITED |
| Owner/operator number | 10051630 |
| 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 | STAAN BIOMED ENGINEERING PRIVATE LIMITED |
| Establishment registrations | 3005698350 |
| FEI numbers | 3005698350 |
| 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