Ion-L Navigated Instruments
Device Facts
| Record ID | K262121 |
|---|---|
| Device Name | Ion-L Navigated Instruments |
| Applicant | SurGenTec, LLC |
| Product Code | OLO · Neurology |
| Decision Date | Jul 24, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
Regulatory Classification
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.
