510(k) K231585 ยท OYK Ankle Arthroplasty Implantation System
Vantage PSI System
| Applicant | 3D Systems, Inc., Littleton CO, US |
| Decision | Substantially Equivalent, Jun 30, 2023 |
| Received | May 31, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231585
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.