510(k) K191698 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
TiN Coated Humeral Head
| Applicant | Fx Shoulder USA, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Jul 16, 2020 |
| Received | Jun 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191698
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.