510(k) K212870 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
TLC Unicompartmental Knee System
| Applicant | Signature Orthopaedics Pty, Ltd., Lane Cove West, AU |
| Decision | Substantially Equivalent, Jun 16, 2022 |
| Received | Sep 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212870
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.