510(k) K090988 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
GMK TOTAL KNEE SYSTEM
| Applicant | Medacta International S.A., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 10, 2009 |
| Received | Apr 7, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090988
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2017 | Medacta Usa Inc The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.