FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
KeYi Total Knee System
K Number: K230120
·
Decision Apr 19, 2024
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
4
Review Days
458
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Basic Information
- Device Name
- KeYi Total Knee System
- K Number
- K230120
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beijing Keyi Medical Device Technology Co., Ltd.
- Date Received
- January 17, 2023
- Decision Date
- April 19, 2024
- Product Code
- JWH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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