FDA 510(k)

Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)

Número K: K262253 · 2026-07-31

Data da decisão2026-07-31

Código do produtoONN

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) is the device name listed in this FDA 510(k) record. The listed applicant is Orthalign, Inc.. It received FDA 510(k) clearance on 2026-07-31 under 510(k) number K262253. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)?

Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is Orthalign, Inc.. The 510(k) number is K262253.

When did Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) receive FDA 510(k) clearance?

Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) received FDA 510(k) clearance on 2026-07-31, under 510(k) number K262253.

Who is the listed applicant for Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)?

The FDA 510(k) record lists Orthalign, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)?

The FDA product code for Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) is ONN.

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Outros registros que listam Orthalign, Inc. como candidato(a)

K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee K242616Lantern® Hip K200892Harvey(R) Surgical Assistant K200642OrthAlign Plus System K172462OrthAlign Plus System K171780OrthAlign Plus System

Ver todos os 10 dispositivos →

Dispositivos Relacionados (Código: ONN)

K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.K252524Quadsense (Quadsense and Quadsense Pro)Eventum Orthopaedics, Ltd.K241298QUADSENSEEventum Orthopaedics, Ltd.K242616Lantern® HipOrthalign, Inc.K220830TrueBalance™ Surgical SystemThese Three Medical, LLC K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for ShoulderOrthosensor, Inc.

Fonte oficial

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