← Product Code [ONN](/productcode/ONN) · K253507

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

_Orthalign, Inc. · ONN · Jun 2, 2026 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K253507

## Device Facts

- **Applicant:** Orthalign, Inc.
- **Product Code:** [ONN](/productcode/ONN.md)
- **Decision Date:** Jun 2, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4560
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

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**Source:** [https://fda.innolitics.com/device/K253507](https://fda.innolitics.com/device/K253507)

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