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) → OJP — Orthopedic Computer Controlled Surgical System

# OJP · Orthopedic Computer Controlled Surgical System

_Neurology · 21 CFR 882.4560 · Class 2_

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

## Overview

- **Product Code:** OJP
- **Device Name:** Orthopedic Computer Controlled Surgical 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K150741](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OJP/K150741.md) | TSolution One w/ACG surgical System | THINK Surgical, Inc. | Oct 22, 2015 | SESE |
| [K140585](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OJP/K140585.md) | CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM | Curexo Technology Corporation | Aug 18, 2014 | SESE |
| [K140038](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OJP/K140038.md) | DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM | Curexo Technology Corporation | May 27, 2014 | SESE |
| [K072629](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OJP/K072629.md) | DIGIMATCH ROBODOC SURGICAL SYSTEM | Integrated Surgical Systems, Inc. | Aug 6, 2008 | SESE |

## Top Applicants

- Curexo Technology Corporation — 2 clearances
- Integrated Surgical Systems, Inc. — 1 clearance
- THINK Surgical, Inc. — 1 clearance

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

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