510(k) K152252 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Arthrex iBalance TKA System
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Nov 16, 2015 |
| Received | Aug 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152252
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.