FDA device listing
3.5 Hex Screw Driver Shaft,Alignment Guide,Broach Handle power adapter,Calcar Reamer, Large,Drill Depth Gauge,Drill…
FDA device listing 1140317696 · HAMAGAWA INDUSTRIAL (M) SDN BHD
Key facts
| Proprietary names | 3.5 Hex Screw Driver Shaft,Alignment Guide,Broach Handle power adapter,Calcar Reamer, Large,Drill Depth Gauge,Drill Guide,Dymaxeon Spine System,IM Drill,Kratos Trial Neck, H/O (Lateralized),Kratos Trial Neck, Standard,Large Reamer Handle,Liner Impactor, 28mm,Liner Impactor, 32mm,Liner Impactor, 36mm,Osteotomy Guide,Quick Connect Drill Shaft,Quick Release Box Osteotome,Quick Release Head… |
|---|---|
| Owner/operator | HAMAGAWA INDUSTRIAL (M) SDN BHD |
| Owner/operator number | 10047158 |
| 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 | HAMAGAWA INDUSTRIAL (M) SDN BHD |
| Establishment registrations | 3008840738 |
| FEI numbers | 3008840738 |
| Establishment operations | Contract 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