510(k) K193432 ยท OYK Ankle Arthroplasty Implantation System
Vantage PSI System
| Applicant | 3D Systems, Littleton CO, US |
| Decision | Substantially Equivalent, Nov 9, 2020 |
| Received | Dec 10, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193432
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.