510(k) K974054 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
DISTAL CENTRALIZER, EXETER II HIP SYSTEM
| Applicant | Howmedica, Inc., Rutherford NJ, US |
| Decision | Substantially Equivalent, Dec 23, 1997 |
| Received | Oct 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974054
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2010 | Stryker Howmedica Osteonics Corp. Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920.
Intended to be used to centralize the femoral stem within the intramedullary canal. intended to be used with bone cement. Terminated |
JDI | None listed |
| May 12, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Accolade Distal Centralizer 14 mm Large; Catalog No.: 1059-6714. For use with Accolade hip prosthesis. Terminated |
JDI | None listed |
| May 12, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Accolade Distal Centralizer 13 mm Medium; Catalog No.: 1059-4513. For use with Accolade hip prosthesis. Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.