510(k) K020381 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
EXPANDABLE KNEE
| Applicant | Biomet Orthopedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 6, 2002 |
| Received | Feb 5, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020381
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2017 | Zimmer Biomet, Inc. RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817 Terminated |
KRO | None listed |
| Jun 5, 2017 | Zimmer Biomet, Inc. RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828 Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.