510(k) K100151 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)
| Applicant | Omnlife Science, Raynham MA, US |
| Decision | Substantially Equivalent, May 28, 2010 |
| Received | Jan 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100151
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.