FDA device listing
GLOBAL UNITE
FDA device listing 1980383663 · DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
Key facts
| Proprietary names | GLOBAL UNITE |
|---|---|
| Owner/operator | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
| Owner/operator number | 1221934 |
| Premarket submissions | K133834 |
| Product codes | HSD, KWS, PHX |
| Device names | HSD - Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, PHX - Shoulder Prosthesis, Reverse Configuration |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3660, 888.3690 |
| Review panels | Orthopedic |
| Registered establishments | DePuy Mitek, Inc. |
| Establishment registrations | 1221934 |
| FEI numbers | 1221934 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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