510(k) K223548 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
GMK Sphere & GMK SpheriKA Cementless
| Applicant | Medacta International S.A., Castel San Pietro (Ch), CH |
| Decision | Substantially Equivalent, Jan 20, 2023 |
| Received | Nov 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223548
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.