← Product Code [SBF](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF) · K252530

# OptiVu™ Shoulder (K252530)

_Mr Surgical Solutions, LLC · SBF · Sep 10, 2025 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94neurological-surgical-devices/SBF/K252530

## Device Facts

- **Applicant:** Mr Surgical Solutions, LLC
- **Product Code:** [SBF](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF.md)
- **Decision Date:** Sep 10, 2025
- **Decision:** SESE
- **Submission Type:** Special
- **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/SBF/K252530](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94neurological-surgical-devices/SBF/K252530)

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