Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560) → OSF — Patient Specific Manual Orthopedic Stereotaxic System

# OSF · Patient Specific Manual Orthopedic Stereotaxic System

_Neurology · 21 CFR 882.4560 · Class 2_

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

## Overview

- **Product Code:** OSF
- **Device Name:** Patient Specific Manual Orthopedic Stereotaxic System
- **Regulation:** [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)

## 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).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K233315](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OSF/K233315.md) | HipXpert and HipInsight System | Surgical Planning Associates, Inc. | Aug 8, 2024 | SESE |
| [K200384](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OSF/K200384.md) | HipXpert 3D Display and Anchoring Application | Surgical Planning Associates, Inc. | Jan 28, 2021 | SESE |
| [K093491](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OSF/K093491.md) | HIP SEXTANT INSTRUMENT SYSTEM | Surgical Planning Associates | Dec 9, 2010 | SESE |

## Top Applicants

- Surgical Planning Associates, Inc. — 2 clearances
- Surgical Planning Associates — 1 clearance

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

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