510(k) K201391 · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Easytech® Anatomical Shoulder System
| Applicant | Fx Shoulder USA, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Feb 16, 2021 |
| Received | May 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201391
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.