Orthalign
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of StrykerLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
- 510(k) clearances: 15
- Device recalls: 2
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Jul 31, 2026 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)K262253 · ONN | 510(k) clearances |
| Jun 2, 2026 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeK253507 · ONN | 510(k) clearances |
| Feb 10, 2026 | Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee SystemClass II · Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) | Device recalls |
| Feb 10, 2026 | Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee SystemClass II · Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) | Device recalls |
| Oct 3, 2024 | Lantern® HipK242616 · ONN | 510(k) clearances |
| Jun 18, 2020 | Harvey(R) Surgical AssistantK200892 · OLO | 510(k) clearances |
| Apr 10, 2020 | OrthAlign Plus SystemK200642 · OLO | 510(k) clearances |
| Nov 22, 2017 | OrthAlign Plus SystemK172462 · OLO | 510(k) clearances |
| Jul 11, 2017 | OrthAlign Plus SystemK171780 · OLO | 510(k) clearances |
| Mar 2, 2017 | KneeAlign 2 SystemK163379 · OLO | 510(k) clearances |
Names and Identifiers
- Appears as
- Website
- orthalign.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built