510(k) K190521 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Aequalis Ascend Flex Shoulder System
| Applicant | Tornier S.A.S., Monbonnot Saint Martin, FR |
| Decision | Substantially Equivalent, Jun 12, 2019 |
| Received | Mar 4, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190521
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.