510(k) K013035 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
GUARDIAN LIMB SALVAGE SYSTEM
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent, Dec 7, 2001 |
| Received | Sep 10, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013035
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2006 | Wright Medical Technology Inc Guardian Distal Femur Axial Pin Terminated |
JDI | None listed |
| Aug 24, 2004 | Wright Medical Technology Inc Guardian Distal Femur Axial Pin Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.