510(k) K203108 ยท PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Ignite Stemless Anatomic Shoulder System
| Applicant | Ignite Orthopedics, LLC, Winona Lake IN, US |
| Decision | Substantially Equivalent, Jul 16, 2021 |
| Received | Oct 15, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203108
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.