FDA device listing
114010040 GLOBAL ICON,114010042 GLOBAL ICON,114010044 GLOBAL ICON,114010046 GLOBAL ICON,114010048 GLOBAL ICON,114010050…
FDA device listing 1338484129 · SWANN MORTON, LTD.
Key facts
| Proprietary names | 114010040 GLOBAL ICON,114010042 GLOBAL ICON,114010044 GLOBAL ICON,114010046 GLOBAL ICON,114010048 GLOBAL ICON,114010050 GLOBAL ICON,114010052 GLOBAL ICON,114010054 GLOBAL ICON,114010056 GLOBAL ICON |
|---|---|
| Owner/operator | SWANN MORTON, LTD. |
| Owner/operator number | 9003320 |
| Product codes | PKC |
| Device names | PKC - Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3660 |
| 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