FDA device listing
4-AXIS KNEE,BASE,COMPACT 4-AXIS KNEE,CONNECTION ADAPTOR,DISTAL LOCKING,Easy Ride,FEMALE PYRAMID CONNECTOR,FOAM…
FDA device listing 1642548763 · PROTEOR USA
Key facts
| Proprietary names | 4-AXIS KNEE,BASE,COMPACT 4-AXIS KNEE,CONNECTION ADAPTOR,DISTAL LOCKING,Easy Ride,FEMALE PYRAMID CONNECTOR,FOAM COVERING,Hydeal Knee,HyTrek,LOCKING KNEE,Matik Knee,PRONG CONNECTOR AND DISH,Proteor Quattro Microprocessor Knee,SINGLE AXIS KNEE W/BRAKE,THREAD CONNECTION ADAPTOR,Trans-Femoral Rotator,TUBE |
|---|---|
| Owner/operator | PROTEOR USA |
| Owner/operator number | 10032353 |
| Product codes | ISY |
| Device names | ISY - Joint, Knee, External Limb Component |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3420 |
| Review panels | Physical Medicine |
| Registered establishments | PROTEOR USA, PROTEOR USA, Gunnison |
| Establishment registrations | 3004737223, 3008584163 |
| FEI numbers | 3004737223, 3008584163 |
| Establishment operations | Complaint File Establishment, 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