510(k) K260090 ยท HRS Plate, Fixation, Bone
SMART Osteotomy System
| Applicant | Actis Medical Pty., Ltd., Torrensville, AU |
| Decision | Substantially Equivalent, Apr 10, 2026 |
| Received | Jan 12, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260090
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.