510(k) K182500 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Catalyst CSR Press-Fit Humeral Components
| Applicant | Catalyst Orthoscience, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Jan 11, 2019 |
| Received | Sep 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182500
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.