510(k) K143552 ยท PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Simpliciti Shoulder System
| Applicant | Tornier, Inc., Bloomington MN, US |
| Decision | Substantially Equivalent, Mar 4, 2015 |
| Received | Dec 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143552
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.