510(k) K103189 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK
| Applicant | Medacta International S.A., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 20, 2010 |
| Received | Oct 28, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103189
| 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.