Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560) → ONA — Computer Assisted Hair Harvesting System

# ONA · Computer Assisted Hair Harvesting System

_Neurology · 21 CFR 882.4560 · Class 2_

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

## Overview

- **Product Code:** ONA
- **Device Name:** Computer Assisted Hair Harvesting System
- **Regulation:** [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)

## 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K173358](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONA/K173358.md) | ARTAS System | Restoration Robotics, Inc. | Mar 16, 2018 | SESE |
| [K123548](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONA/K123548.md) | THE ARTAS SYSTEM | Restoration Robotics, Inc. | Feb 25, 2013 | SESE |
| [K123154](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONA/K123154.md) | ARTAS SYSTEM FROM RESTORATION ROBOTICS | Restoration Robotics, Inc. | Feb 19, 2013 | SESE |
| [K103428](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONA/K103428.md) | THE ARTAS SYSTEM FROM RESTORATION ROBOTICS | Restoration Robotics, Inc. | Apr 4, 2011 | SESE |

## Top Applicants

- Restoration Robotics, Inc. — 4 clearances

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONA](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONA)

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