FDA device listing
KANAPOLY, KPK203 Multi-Axis Pneumatic Knee Joint,KANAPOLY, KPK401 Multi-Axis Hydraulic Knee Joint,KANAPOLY, KPK403…
FDA device listing 1325201659 · Kanapo Prosthetics and Orthotics Ltd.
Key facts
| Proprietary names | KANAPOLY, KPK203 Multi-Axis Pneumatic Knee Joint,KANAPOLY, KPK401 Multi-Axis Hydraulic Knee Joint,KANAPOLY, KPK403 Multi-Axis Hydraulic Knee Joint with Geometry Locking |
|---|---|
| Owner/operator | Kanapo Prosthetics and Orthotics Ltd. |
| Owner/operator number | 10094504 |
| 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 | KANAPO PROSTHETICS AND ORTHOTICS LTD. |
| Establishment registrations | 3043049054 |
| FEI numbers | 3043049054 |
| 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