510(k) K152315 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
JOURNEY II Uni Tibial Base and Insert
| Applicant | Smith & Nephew, Inc., Cordova TN, US |
| Decision | Substantially Equivalent, Oct 28, 2015 |
| Received | Aug 17, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152315
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.