FDA device listing
CMD 23-1434 Promade Elbow,CMD 24-1060 ProMade Elbow,CMD 24-1099 ProMade Elbow,CMD 25-1026 ProMade Elbow,CMD 25-1263…
FDA device listing 1980973266 · Limacorporate S.p.A.
Key facts
| Proprietary names | CMD 23-1434 Promade Elbow,CMD 24-1060 ProMade Elbow,CMD 24-1099 ProMade Elbow,CMD 25-1026 ProMade Elbow,CMD 25-1263 ProMade Elbow,CMD 25-1400 ProMade Elbow,CMD 25-1650 ProMade Elbow,CMD 25-1755 ProMade Elbow,CMD 26-1008 ProMade Elbow,CMD 26-1163 ProMade Elbow,CMD 26-1256 ProMade Elbow |
|---|---|
| Owner/operator | Limacorporate S.p.A. |
| Owner/operator number | 10032506 |
| Product codes | PIX |
| Device names | PIX - Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.PIX |
| Review panels | Orthopedic |
| Registered establishments | Limacorporate S.p.A. |
| Establishment registrations | 3008021110 |
| FEI numbers | 3008021110 |
| 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