Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee
Device Facts
| Record ID | K253507 |
|---|---|
| Device Name | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee |
| Applicant | Orthalign, Inc. |
| Product Code | ONN · Neurology |
| Decision Date | Jun 2, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.
