FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
UKNEE TOTAL KNEE SYSTEM
K Number: K021657
·
Decision Aug 12, 2002
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
20
Review Days
84
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Basic Information
- Device Name
- UKNEE TOTAL KNEE SYSTEM
- K Number
- K021657
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- United Orthopedic Corp.
- Date Received
- May 20, 2002
- Decision Date
- August 12, 2002
- 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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Other Clearances by United Orthopedic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K140073 | U2 FEMORAL COMPONENT, CR, CEMENTED | Jun 16, 2014 | Substantially Equivalent |
| K140075 | U2 FEMORAL COMPONENT, CR, POROUS COATED | Jun 13, 2014 | Substantially Equivalent |
| K132455 | U-MOTION II PS+ CUP | Sep 3, 2013 | Substantially Equivalent |
| K122185 | U-MOTION II ACETABULAR SYSTEM | Feb 22, 2013 | Substantially Equivalent |
| K122183 | AUGMENT AND SCREW, PSA TYPE | Feb 5, 2013 | Substantially Equivalent |
| K121777 | U2 ACETABULAR CUP, PLASMA SPRAY | Jul 18, 2012 | Substantially Equivalent |
| K111546 | U2 HIP SYSTEM | Jul 1, 2011 | Substantially Equivalent |
| K103497 | CERAMIC FEMORAL HEAD | Mar 4, 2011 | Substantially Equivalent |
| K101670 | UNITED U2 BIPOLAR IMPLANT | Oct 8, 2010 | Substantially Equivalent |
| K100981 | UNITED STEM, PSA TYPE | Jun 14, 2010 | Substantially Equivalent |