510(k) K190595 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Signature ONE System
| Applicant | Orthosoft Inc (D/B/A Zimmer Cas), Montreal, CA |
| Decision | Substantially Equivalent, Jun 5, 2019 |
| Received | Mar 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190595
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.