FDA device listing
M-Vizion Monobloc
FDA device listing 1151770760 · Medacta International SA
Key facts
| Proprietary names | M-Vizion Monobloc |
|---|---|
| Owner/operator | Medacta International SA |
| Owner/operator number | 10024526 |
| Premarket submissions | K212327 |
| Product codes | KWY, LZO |
| Device names | KWY - Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3353, 888.3390 |
| Review panels | Orthopedic |
| Registered establishments | MEDACTA INTERNATIONAL SA |
| Establishment registrations | 3005180920, 3008110533 |
| FEI numbers | 3005180920, 3008110533 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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