FDA device listing
124580049 Duraloc Hip System,124580050 Duraloc Hip System,124580051 Duraloc Hip System,124580052 Duraloc Hip…
FDA device listing 1610536681 · SWANN MORTON, LTD.
Key facts
| Proprietary names | 124580049 Duraloc Hip System,124580050 Duraloc Hip System,124580051 Duraloc Hip System,124580052 Duraloc Hip System,124580053 Duraloc Hip System,124580054 Duraloc Hip System,124580055 Duraloc Hip System,124580056 Duraloc Hip System,124580057 Duraloc Hip System,124580058 Duraloc Hip System,124946000 Acetabular Revision Components |
|---|---|
| Owner/operator | SWANN MORTON, LTD. |
| Owner/operator number | 9003320 |
| Product codes | LPH |
| Device names | LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 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