510(k) K133854 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ARTHREX IBALANCE TKA SYSTEM
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Feb 27, 2014 |
| Received | Dec 19, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133854
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.