FDA device listing
VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL
FDA device listing 1815644960 · ZIMMER, INC.
Key facts
| Proprietary names | VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL |
|---|---|
| Owner/operator | ZIMMER, INC. |
| Owner/operator number | 1822565 |
| Premarket submissions | K141407 |
| Product codes | JWH, MBH, MBV, OIY |
| Device names | JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, MBH - Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, MBV - Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer, OIY - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3560, 888.3565 |
| Review panels | Orthopedic |
| Registered establishments | Zimmer Biomet Canada DFE |
| Establishment registrations | 3012392319 |
| FEI numbers | 3012392319 |
| Establishment operations | Foreign Exporter |
| 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