510(k) K261145 ยท HRS Plate, Fixation, Bone
Avanti Distal Elbow ORIF System
| Applicant | Avanti Orthopaedics, LLC, Wilmington DE, US |
| Decision | Substantially Equivalent, May 9, 2026 |
| Received | Apr 7, 2026 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K261145
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.