FDA device listing
ADJUS TEMPORARY SOCKET,KEASY,Silitouch,Stepline
FDA device listing 1020479509 · PROTEOR USA
Key facts
| Proprietary names | ADJUS TEMPORARY SOCKET,KEASY,Silitouch,Stepline |
|---|---|
| Owner/operator | PROTEOR USA |
| Owner/operator number | 10032353 |
| Product codes | ISS |
| Device names | ISS - Prosthesis, Thigh Socket, External 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