510(k) K161366 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
| Applicant | Conformis, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Jun 14, 2016 |
| Received | May 17, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161366
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.