FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Balanced Knee Revision System - Offset Junction Box
K Number: K180743
·
Decision Jun 20, 2018
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
14
Review Days
90
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Basic Information
- Device Name
- Balanced Knee Revision System - Offset Junction Box
- K Number
- K180743
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Development Corporation
- Date Received
- March 22, 2018
- Decision Date
- June 20, 2018
- 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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