510(k) K212683 ยท PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
GLOBAL ICON Stemless Shoulder System
| Applicant | Depuy(Ireland), Cork, IE |
| Decision | Substantially Equivalent, Jan 19, 2022 |
| Received | Aug 24, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212683
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.