510(k) K991026 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Oct 22, 1999 |
| Received | Mar 29, 1999 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K991026
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2009 | Smith & Nephew Inc Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.