FDA device listing
101836500 Pinnacle Hip System,101836503 Pinnacle Hip System,101836505 Pinnacle Hip System,101836508 Pinnacle Hip…
FDA device listing 1207421496 · SWANN MORTON, LTD.
Key facts
| Proprietary names | 101836500 Pinnacle Hip System,101836503 Pinnacle Hip System,101836505 Pinnacle Hip System,101836508 Pinnacle Hip System,101836511 Pinnacle Hip System,136526000 Pinnacle Hip System,136531000 Pinnacle Hip System,136532000 Pinnacle Hip System,136533000 Pinnacle Hip System,136534000 Pinnacle Hip System,136536000 Pinnacle Hip System,136555000 Pinnacle Hip System |
|---|---|
| Owner/operator | SWANN MORTON, LTD. |
| Owner/operator number | 9003320 |
| Product codes | JDI, LPH |
| Device names | JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3350, 888.3358 |
| Review panels | Orthopedic |
| Registered establishments | Swann-Morton(Services) Limited |
| Establishment registrations | 3008812251 |
| FEI numbers | 3002808293 |
| 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