510(k) K220495 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
SignaSure Dual Mobility System
| Applicant | Signature Orthopaedics Pty, Ltd., Lane Cove West, AU |
| Decision | Substantially Equivalent, Jan 13, 2023 |
| Received | Feb 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220495
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.