← Product Code [HAW](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW) · K002053

# NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 (K002053)

_Orthosoft, Inc. · HAW · Aug 3, 2000 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K002053

## Device Facts

- **Applicant:** Orthosoft, Inc.
- **Product Code:** [HAW](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW.md)
- **Decision Date:** Aug 3, 2000
- **Decision:** SESE
- **Submission Type:** Special
- **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/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K002053](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K002053)

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