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Orthalign, Inc.

15 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) (K262253)Orthalign, Inc.2026-07-31
Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee (K253507)Orthalign, Inc.2026-06-02
Lantern® Hip (K242616)Orthalign, Inc.2024-10-03
Harvey(R) Surgical Assistant (K200892)Orthalign, Inc.2020-06-18
OrthAlign Plus System (K200642)Orthalign, Inc.2020-04-10
OrthAlign Plus System (K172462)Orthalign, Inc.2017-11-22
OrthAlign Plus System (K171780)Orthalign, Inc.2017-07-11
KneeAlign 2 System (K163379)Orthalign, Inc.2017-03-02
OrthAlign Plus System (K162962)Orthalign, Inc.2017-01-23
OrthAlign Plus System (K153237)Orthalign, Inc.2016-03-01
ORTHALIGN PLUS SYSTEM (K140331)Orthalign, Inc.2014-06-10
ORTHOALIGN PLUS SYSTEM (K130387)Orthalign, Inc.2013-11-08
KNEEALIGN SYSTEM (K103829)Orthalign, Inc.2011-04-04
KNEEALIGN SYSTEM WITH REFERENCE SENSOR (K093998)Orthalign, Inc.2010-03-22
KNEEALIGN SYSTEM (K091411)Orthalign, Inc.2009-09-25

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Every clearance here is in the API, with alerts when new ones post.