510(k) K200892 ยท OLO Orthopedic Stereotaxic Instrument
Harvey(R) Surgical Assistant
| Applicant | Orthalign, Inc., Aliso Viejo CA, US |
| Decision | Substantially Equivalent, Jun 18, 2020 |
| Received | Apr 3, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200892
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2026 | Orthalign, Inc Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5
REF:402566
component Lantern Knee System Open, Classified |
OLO | None listed |
| Mar 24, 2026 | Orthalign, Inc Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7
REF:402567
component Lantern Knee System Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.