510(k) K153609 ยท KWH Prosthesis, Toe, Constrained, Polymer
RTS Flexible 1 MPJ Implant w/Grommets
| Applicant | In2bones USA, LLC, Memphis TN, US |
| Decision | Substantially Equivalent, Sep 8, 2016 |
| Received | Dec 17, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153609
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.