510(k) K253507 ยท ONN Intraoperative Orthopedic Joint Assessment Aid
Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee
| Applicant | Orthalign, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 2, 2026 |
| Received | Nov 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253507
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.