510(k) K181635 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
GMK Sphere CR Tibial Inserts
| Applicant | Medacta International S.A., Castel San Pietro (Ch), CH |
| Decision | Substantially Equivalent, Aug 23, 2018 |
| Received | Jun 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181635
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.