DeviceClearance

Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee— 510(k) K253507

Substantially Equivalent

Orthalign, Inc.

FDA 510(k) clearance K253507 for Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee, Substantially Equivalent on 2026-06-02. Applicant: Orthalign, Inc..

Clearance details

Applicant
Orthalign, Inc.
Product code
Code ONN
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

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