510(k) K111546 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
U2 HIP SYSTEM
| Applicant | United Orthopedic Corp., Hsinchu, TW |
| Decision | Substantially Equivalent, Jul 1, 2011 |
| Received | Jun 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111546
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2013 | Orthopedic Alliance LLC Femoral head, standard, 26mm, +0mm
Femoral head,medium, 26mm,+3mm
Femoral head, long, 26mm, +6mm
Femoral head, X-long, 26mm, +9mm
Femoral head, 28mm, -3mm
Femoral head, 28mm, +0mm
Femoral head, 28mm, Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.