510(k) K203447 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement
| Applicant | Conformis, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, Dec 22, 2020 |
| Received | Nov 23, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203447
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.