510(k) K181340 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cemented TSI Hip Stem
| Applicant | Signature Orthopaedics Pty, Ltd., Lane Cove West, AU |
| Decision | Substantially Equivalent, Feb 11, 2019 |
| Received | May 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181340
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.