FDA device listing
Alignment Tube,Alignment Tube for Humerus Nail,Assemble Bolt,Assemble Bolt Driver,Assemble Bolt Driver For CHN,Assemble…
FDA device listing 1867711335 · TDM Co.,Ltd
Key facts
| Proprietary names | Alignment Tube,Alignment Tube for Humerus Nail,Assemble Bolt,Assemble Bolt Driver,Assemble Bolt Driver For CHN,Assemble Bolt For CHN,Assemble Bolt for Retrograde,Assemble/Extract Bolt,Assemble/Extract Bolt With Tip,Assemble/Extract Rod,Assemble Handle,Assemble Handle for Femur,Assemble Handle for Tibia,Assemble Handle with Shaft for CHN,Bar Introducer Large(PMI-023),Bar Introducer… |
|---|---|
| Owner/operator | TDM Co.,Ltd |
| Owner/operator number | 10057351 |
| 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 | TDM CO.,LTD |
| Establishment registrations | 3014257776 |
| FEI numbers | 3014257776 |
| 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