510(k) K032300 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
ACCOLADE-J HIP STEM SERIES
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Oct 9, 2003 |
| Received | Jul 25, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032300
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2011 | Stryker Howmedica Osteonics Corp. Accolade TMZF Plus Hip Stem:
Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5
Catalog #6020-3535 Accolade 132 Size 3.5
Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2
Catalog # 6021-0335 Acco Terminated |
ISL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.