FDA device listing
121848041-11 PINNACLE Hip Solutions,121850043-11 PINNACLE Hip Solutions,121852045-11 PINNACLE Hip Solutions,121854047-11…
FDA device listing 1096246347 · SWANN MORTON, LTD.
Key facts
| Proprietary names | 121848041-11 PINNACLE Hip Solutions,121850043-11 PINNACLE Hip Solutions,121852045-11 PINNACLE Hip Solutions,121854047-11 PINNACLE Hip Solutions,121856049-11 PINNACLE Hip Solutions,121858049-11 PINNACLE Hip Solutions,121860051-11 PINNACLE Hip Solutions,121862053-11 PINNACLE Hip Solutions,121864053-11 PINNACLE Hip Solutions,121866055-11 PINNACLE Hip Solutions,PINNACLE DM LINER 48_41,PINNACLE DM… |
|---|---|
| Owner/operator | SWANN MORTON, LTD. |
| Owner/operator number | 9003320 |
| Product codes | LPH, LZO, MEH |
| Device names | LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, MEH - Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3353, 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