510(k) K121777 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
U2 ACETABULAR CUP, PLASMA SPRAY
| Applicant | United Orthopedic Corp., Hsinchu, TW |
| Decision | Substantially Equivalent, Jul 18, 2012 |
| Received | Jun 18, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121777
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2013 | Orthopedic Alliance LLC U2 Acetabular cup, Ti beads porous coated, 44mm
U2 Acetabular cup, Ti beads porous coated, 46mm
U2 Acetabular cup, Ti beads porous coated, 48mm
U2 Acetabular cup, Ti beads porous coated, 50mm
U2 Aceta Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.