510(k) K223326 ยท OYK Ankle Arthroplasty Implantation System
Axiom PSR System
| Applicant | Restor3D, Durham NC, US |
| Decision | Substantially Equivalent, Mar 30, 2023 |
| Received | Oct 31, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223326
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | restor3d Inc. Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006 Open, Classified |
OYK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.