UNITED U2 FEMORAL COMPONENT, PS, #7
FDA 510(k) clearance K120507 · decided 2012-05-04
Clearance details
- K-number
- K120507
- Device name
- UNITED U2 FEMORAL COMPONENT, PS, #7
- Applicant
- United Orthopedic Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-02-21
- Decision date
- 2012-05-04
- Days to decision
- 73 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, l recall (Z-1378-2013) | Orthopedic Alliance LLC | 2013-05-24 |