510(k) K193105 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System
| Applicant | Conformis, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, Mar 13, 2020 |
| Received | Nov 8, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193105
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.