FDA device listing
Paragon 28 Custom Made Devices
FDA device listing 1631867780 · Paragon 28
Key facts
| Proprietary names | Paragon 28 Custom Made Devices |
|---|---|
| Owner/operator | Paragon 28 |
| Owner/operator number | 10033376 |
| Product codes | HSN |
| Device names | HSN - Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3110 |
| Review panels | Orthopedic |
| Registered establishments | PARAGON 28 |
| Establishment registrations | 3008650117 |
| FEI numbers | 3008650117 |
| 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