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Orthalign, Inc.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories2
Latest FDA decision2026-07-31
TypeNumberDevice NameCodeDateActions
510(k) K262253 Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)ONN2026-07-31 View
510(k) K253507 Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeONN2026-06-02 View
510(k) K242616 Lantern® HipONN2024-10-03 View
510(k) K200892 Harvey(R) Surgical AssistantOLO2020-06-18 View
510(k) K200642 OrthAlign Plus SystemOLO2020-04-10 View
510(k) K172462 OrthAlign Plus SystemOLO2017-11-22 View
510(k) K171780 OrthAlign Plus SystemOLO2017-07-11 View
510(k) K163379 KneeAlign 2 SystemOLO2017-03-02 View
510(k) K162962 OrthAlign Plus SystemOLO2017-01-23 View
510(k) K153237 OrthAlign Plus SystemOLO2016-03-01 View
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