FDA device listing
Acetabular Reamer,Ball Joint Driver,Bipolar Head Fitting Jig,Bipolar Head Inserter,Bipolar Scissors,Calcar Reamer,Clutch…
FDA device listing 1484905016 · Signature Orthopaedics Pty Limited
Key facts
| Proprietary names | Acetabular Reamer,Ball Joint Driver,Bipolar Head Fitting Jig,Bipolar Head Inserter,Bipolar Scissors,Calcar Reamer,Clutch Screw Driver,Cup Inserter,Femoral Broach,Femoral Head Extractor,Femoral Sound,Flexible Driver,Head Extractor,Head Impactor,Imboki Instrument Set,Instrument Tray,Lightning Curved Reamer Handle,Liner Collar Popper,Liner Impactor,Liner Inserter,Monobloc Hex Driver,Multi Axial Hex… |
|---|---|
| Owner/operator | Signature Orthopaedics Pty Limited |
| Owner/operator number | 10037793 |
| 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 | Signature Orthopaedics Europe Ltd, SIGNATURE ORTHOPAEDICS PTY LIMITED |
| Establishment registrations | 3008262872, 3014763043 |
| FEI numbers | 3008262872, 3014763043 |
| Establishment operations | Manufacturer, Specification Developer |
| 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