Data / Medical devices / China / Beijing Ikey Medical Device Technology Co., Ltd.
Beijing Ikey Medical Device Technology Co., Ltd.: FDA-registered device maker in Beijing, China, 2 510(k) clearances
Beijing Ikey Medical Device Technology Co., Ltd. is registered with the FDA (registration 3040391045) in Beijing, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 19, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3040391045
- Address
- Floor 1-2, Building 1, 30 Yongchang South Road Beijing, CN 100176, Beijing, China, 100176
- Owner or operator
- Beijing iKey Medical Device Technology Co., Ltd. (10093962)
- Roles
- Manufacturer
- First device listed
- August 25, 2025
- Registered through
- 2026
- Brand names listed
- KeYi Total Knee System, iKey Total Hip System/KeYi Total Hip System, iKey Total Knee System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 19, 2024 | K230120 | KeYi Total Knee System | JWH | Substantially Equivalent | Beijing Keyi Medical Device Technology Co., Ltd. | accessdata.fda.gov |
| May 14, 2020 | K191826 | KeYi Total Hip System | LPH | Substantially Equivalent | Beijing Keyi Medical Device Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Updated April 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.