FDA device listing
4 SIDED I-RATCHET HANDLE,ANTI TORQUE,ANTI TORQUE DRIVER,ANTI TORQUE HANDLE,ANTI TORQUE SLEEVE,BALL POINT TESTER,BONE…
FDA device listing 1241433595 · BK MEDITECH CO., LTD.
Key facts
| Proprietary names | 4 SIDED I-RATCHET HANDLE,ANTI TORQUE,ANTI TORQUE DRIVER,ANTI TORQUE HANDLE,ANTI TORQUE SLEEVE,BALL POINT TESTER,BONE FILLER,CAGE SUPPORT,CLIP WRENCH,DEROTATION CLIP,DEROTATOR HANDLE,DEROTATOR LINKAGE,DISTRACTION SCREW,DISTRACTOR,DYE INJECTOR,EXTRACTOR,FASCIA CUTTER,GRAFT CASE,GUIDE PIN(L),GUIDE PIN(R),GUIDE WIRE,INJECTOR WRENCH,INNER ANTI TORQUE,INTER LINK,INTER LINK CROSS BAR,I-TYPE RATCHET… |
|---|---|
| Owner/operator | BK MEDITECH CO., LTD. |
| Owner/operator number | 9059102 |
| 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 | BK MEDITECH CO., LTD. |
| Establishment registrations | 3004176895 |
| FEI numbers | 3004176895 |
| 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