FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
UNITED U2 BIPOLAR IMPLANT
K Number: K101670
·
Decision Oct 8, 2010
Classifications
1
FEI Numbers
216
Registration Numbers
216
Same Product Code
98
Applicant Total
20
Review Days
116
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- UNITED U2 BIPOLAR IMPLANT
- K Number
- K101670
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3390
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- United Orthopedic Corp.
- Date Received
- June 14, 2010
- Decision Date
- October 8, 2010
- Product Code
- KWY
- 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 |
|---|---|---|---|
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWY), ordered by most recent decision date.
b-ONE® Bipolar Head
FDA 510(k)
FDA Class 2
·Orthopedic
Maxx Libertas Bipolar Hip Head (Bipolar Hip)
FDA 510(k)
FDA Class 2
·Orthopedic
CORAIL Cemented Femoral Stem
FDA 510(k)
FDA Class 2
·Orthopedic
SpaceFlex Acetabular Cup
FDA 510(k)
FDA Class 2
·Orthopedic
Vario-Cup System
FDA 510(k)
FDA Class 2
·Orthopedic
COPAL exchange G hip spacer
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| K100981 | UNITED STEM, PSA TYPE | Jun 14, 2010 | Substantially Equivalent |
| K082424 | UNITED U2 TOTAL KNEE SYSTEM | Dec 16, 2008 | Substantially Equivalent |