510(k) K082792 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS
| Applicant | Medacta International S.A., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 29, 2008 |
| Received | Sep 23, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082792
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2013 | Medacta Usa Inc Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System.
Product Usage - used to broach the intramedullary canal of the femur in order to create Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.