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FDA 510(k)

Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee

K-Number: K253507 · 2026-06-02

ApplicantOrthalign, Inc.
Decision Date2026-06-02
Product CodeONN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee is the device name listed in this FDA 510(k) record. The listed applicant is Orthalign, Inc.. It received FDA 510(k) clearance on 2026-06-02 under 510(k) number K253507. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee?

Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is Orthalign, Inc.. The 510(k) number is K253507.

When did Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee receive FDA 510(k) clearance?

Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee received FDA 510(k) clearance on 2026-06-02, under 510(k) number K253507.

Who is the listed applicant for Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee?

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 Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee?

The FDA product code for Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee is ONN.

Other records listing Orthalign, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)K242616Lantern® HipK200892Harvey(R) Surgical AssistantK200642OrthAlign Plus SystemK172462OrthAlign Plus SystemK171780OrthAlign Plus System

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Related Devices (Code: ONN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.K252524Quadsense (Quadsense and Quadsense Pro)Eventum Orthopaedics, Ltd.K241298QUADSENSEEventum Orthopaedics, Ltd.K242616Lantern® HipOrthalign, Inc.K220830TrueBalance™ Surgical SystemThese Three Medical, LLCK200587VERASENSE 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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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