510(k) K100886 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
INBONE II TOTAL ANKLE REPLACEMENT
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent, Aug 26, 2010 |
| Received | Mar 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100886
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2021 | Wright Medical Technology Inc INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS Terminated |
HSN | None listed |
| Nov 4, 2021 | Wright Medical Technology Inc INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS Terminated |
HSN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.