510(k) K190704 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Signature Ceramic Femoral Head
| Applicant | Signature Orthopaedics Pty, Ltd., Lane Cove West, AU |
| Decision | Substantially Equivalent, Aug 28, 2019 |
| Received | Mar 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190704
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.