510(k) K843909 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
TITANIUM HIP 1019
| Applicant | Depuy, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 15, 1984 |
| Received | Oct 3, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843909
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2021 | DePuy Orthopaedics, Inc. DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis.
Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.