FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Journey II Unicompartmental Knee System
K Number: K190085
·
Decision Feb 11, 2019
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
113
Applicant Total
529
Review Days
25
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Basic Information
- Device Name
- Journey II Unicompartmental Knee System
- K Number
- K190085
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3520
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew, Inc.
- Date Received
- January 17, 2019
- Decision Date
- February 11, 2019
- Product Code
- HSX
- 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 |
|---|---|---|---|
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
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