FDA device listing
Proven Gen-Flex PS Knee Sysytem
FDA device listing 1710591794 · FPD Company
Key facts
| Proprietary names | Proven Gen-Flex PS Knee Sysytem |
|---|---|
| Owner/operator | FPD Company |
| Owner/operator number | 10044979 |
| Product codes | JDI, LZO |
| Device names | JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3350, 888.3353 |
| Review panels | Orthopedic |
| Registered establishments | TRIGON INCORPORATED |
| Establishment registrations | 3010468876 |
| FEI numbers | 3005601732 |
| Establishment operations | Contract 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