21 CFR 882.4560 — Neurological Stereotaxic Instrument
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4560
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 2 | 422 | |
| OEW | Tracking, Soft Tissue, Intraoperative | 2 | 4 | Life-Sustaining |
| OJP | Orthopedic Computer Controlled Surgical System | 2 | 4 | |
| OLO | Orthopedic Stereotaxic Instrument | 2 | 423 | |
| ONA | Computer Assisted Hair Harvesting System | 2 | 4 | |
| ONN | Intraoperative Orthopedic Joint Assessment Aid | 2 | 16 | |
| ORR | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri | 2 | 4 | SaMD |
| OSE | Patient Specific Manual Navigation System | 2 | 0 | SaMD |
| OSF | Patient Specific Manual Orthopedic Stereotaxic System | 2 | 3 | SaMD |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 2 | 36 | SaMD |
| QRI | Surgical Planning Software For Neurological Stereotaxic Instruments | 2 | 1 | SaMD |
| SBF | Orthopedic Augmented Reality | 2 | 41 | SaMD |
| SGE | Extracranial Positional System For A Transcranial Magnetic Stimulation System | 2 | 1 | SaMD |
