FDA device listing
Augment Glenoid Check Guide,Augment Reamer,Augment Reamer Driver
FDA device listing 1293369585 · DONSON MACHINE COMPANY
Key facts
| Proprietary names | Augment Glenoid Check Guide,Augment Reamer,Augment Reamer Driver |
|---|---|
| Owner/operator | DONSON MACHINE COMPANY |
| Owner/operator number | 9057685 |
| Product codes | KWS, KWT |
| Device names | KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, KWT - Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3650, 888.3660 |
| Review panels | Orthopedic |
| Registered establishments | DONSON MACHINE COMPANY |
| Establishment registrations | 3004153896 |
| FEI numbers | 3004153896 |
| Establishment operations | Contract Manufacturer |
| 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