510(k) K203100 ยท PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Arthrex Eclipse Titanium Humeral Head
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Nov 20, 2020 |
| Received | Oct 14, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203100
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.