510(k) K191811 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Catalyst OrthoScience CSR Shoulder System
| Applicant | Catalyst Orthoscience, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Sep 11, 2019 |
| Received | Jul 5, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191811
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.