ONA · Computer Assisted Hair Harvesting System
Neurology · 21 CFR 882.4560 · Class 2
Overview
| Product Code | ONA |
|---|---|
| Device Name | Computer Assisted Hair Harvesting System |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
| Review Panel | Neurology |
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 | ARTAS System | Restoration Robotics, Inc. | Mar 16, 2018 | SESE |
| K123548 | THE ARTAS SYSTEM | Restoration Robotics, Inc. | Feb 25, 2013 | SESE |
| K123154 | ARTAS SYSTEM FROM RESTORATION ROBOTICS | Restoration Robotics, Inc. | Feb 19, 2013 | SESE |
| K103428 | THE ARTAS SYSTEM FROM RESTORATION ROBOTICS | Restoration Robotics, Inc. | Apr 4, 2011 | SESE |
Top Applicants
- Restoration Robotics, Inc. — 4 clearances
