510(k) K163081 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
40-42mm BiPolar Head and 22mm Femoral Head
| Applicant | Signature Orthopaedics Pty, Ltd., Lane Cove West, AU |
| Decision | Substantially Equivalent, Jan 29, 2018 |
| Received | Nov 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163081
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.