UNITED U2 XPE TOTAL KNEE SYSTEM
FDA 510(k) clearance K103733 · decided 2011-08-02
Clearance details
- K-number
- K103733
- Device name
- UNITED U2 XPE TOTAL KNEE SYSTEM
- Applicant
- United Orthopedic Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-12-22
- Decision date
- 2011-08-02
- Days to decision
- 223 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Hsinchu, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial basep recall (Z-1379-2013) | Orthopedic Alliance LLC | 2013-05-24 |
| UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 recall (Z-1380-2013) | Orthopedic Alliance LLC | 2013-05-24 |