FDA device listing
Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads
FDA device listing 1427931998 · I-Medical Asia Company Limited
Key facts
| Proprietary names | Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads |
|---|---|
| Owner/operator | I-Medical Asia Company Limited |
| Owner/operator number | 10085603 |
| Premarket submissions | K182799 |
| Product codes | KWS |
| Device names | KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3660 |
| Review panels | Orthopedic |
| Registered establishments | I-MEDICAL ASIA COMPANY LIMITED |
| Establishment registrations | 3015806723 |
| FEI numbers | 3015806723 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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