FDA device listing
S&N (DK) - PROMOS STD,ZimmerGmbH8803 (DK) - Wagner Cone Prosthesis®
FDA device listing 1971216685 · STERIS Corporation
Key facts
| Proprietary names | S&N (DK) - PROMOS STD,ZimmerGmbH8803 (DK) - Wagner Cone Prosthesis® |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10042227 |
| Product codes | JDI, KWZ, LPH, LZO |
| Device names | JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, KWZ - Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3310, 888.3350, 888.3353, 888.3358 |
| Review panels | Orthopedic |
| Registered establishments | STERIS Schweiz AG |
| Establishment registrations | 8043792 |
| FEI numbers | 3002808269 |
| Establishment operations | Contract Sterilizer |
| 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