← Product Code [OLO](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO) · K260011

# Foundation Surgical Navigated Lateral Disc Prep Instruments (K260011)

_Foundation Surgical Group, Inc. · OLO · Apr 16, 2026 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94neurological-surgical-devices/OLO/K260011

## Device Facts

- **Applicant:** Foundation Surgical Group, Inc.
- **Product Code:** [OLO](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO.md)
- **Decision Date:** Apr 16, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4560
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94neurological-surgical-devices/OLO/K260011](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94neurological-surgical-devices/OLO/K260011)

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