510(k) K140749 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
INFINITY TOTAL ANKLE SYSTEM
| Applicant | Wrightmedicaltechnologyinc, Memphis TN, US |
| Decision | Substantially Equivalent, Apr 25, 2014 |
| Received | Mar 25, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140749
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2022 | Wright Medical Technology, Inc. Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System. Open, Classified |
HSN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.