U2 HIP SYSTEM
FDA 510(k) clearance K111546 · decided 2011-07-01
Clearance details
- K-number
- K111546
- Device name
- U2 HIP SYSTEM
- Applicant
- United Orthopedic Corp.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-03
- Decision date
- 2011-07-01
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- 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 head, standard, 26mm, +0mm Femoral head,medium, 26mm,+3mm Femoral head, long, 26mm recall (Z-1382-2013) | Orthopedic Alliance LLC | 2013-05-24 |