510(k) K181420 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Aequalis Flex Revive Shoulder System
| Applicant | Tornier, Inc., Bloomington MN, US |
| Decision | Substantially Equivalent, Sep 20, 2018 |
| Received | May 31, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181420
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.