FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
OPTIGEN TOTAL KNEE SYSTEM
K Number: K102367
·
Decision Dec 8, 2010
Classifications
1
FEI Numbers
320
Registration Numbers
320
Same Product Code
902
Applicant Total
12
Review Days
110
Basic Information
- Device Name
- OPTIGEN TOTAL KNEE SYSTEM
- K Number
- K102367
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- U&I CORP.
- Date Received
- August 20, 2010
- Decision Date
- December 8, 2010
- 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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