510(k) K011138 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jul 10, 2001 |
| Received | Apr 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011138
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2011 | Biomet U.K., Ltd. Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138)
This device is used in partial knee replacement surgery as a Terminated |
HRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.