510(k) K151459 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Integra Total Ankle Replacement System
| Applicant | Ascension Orthopedics, Austin TX, US |
| Decision | Substantially Equivalent, Aug 31, 2015 |
| Received | Jun 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151459
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2017 | Integra LifeSciences Corp. Integra Cadence Total Ankle System Terminated |
HSN | None listed |
| Apr 29, 2016 | Integra LifeSciences Corp. Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for moveme Terminated |
HSN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.