510(k) K022437 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
UNI KNEE
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Aug 23, 2002 |
| Received | Jul 25, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022437
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2007 | Encore Medical, Lp EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758. Terminated |
HRY | None listed |
| Oct 10, 2007 | Encore Medical, Lp EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758. Terminated |
HWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.