FDA device listing
CrossRoads AO Driver Handle Assembly,DynaForce Step Staple Threaded Handle
FDA device listing 1031436528 · Instrumedical Technologies, Inc.
Key facts
| Proprietary names | CrossRoads AO Driver Handle Assembly,DynaForce Step Staple Threaded Handle |
|---|---|
| Owner/operator | Instrumedical Technologies, Inc. |
| Owner/operator number | 10042092 |
| 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 | INSTRU-MED TECHNOLOGIES |
| Establishment registrations | 1833920 |
| FEI numbers | 1000115656 |
| 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