Pure Global

Stereotactic surgery system, orthopaedic

Access comprehensive regulatory information for Stereotactic surgery system, orthopaedic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Im is sponsored by Surgical Specialties Pty Ltd, manufactured by PIXEE MEDICAL in France. The device registration started on April 15, 2021.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class Im
Class Im
Stereotactic surgery system, orthopaedic
Australia TGA ARTG Registered Device
Good Name: Surgical Specialties Pty Ltd - Stereotactic surgery system, orthopaedic
Pure Global
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Intended Purpose

Standalone software included in a stereotaxic system dedicated to intraoperative use in orthopaedic surgery. It uses an execution platform (augmented reality glasses) to locate specific instruments in a 3D reference frame and is equipped with markers to provide anatomical landmarks and axes.

Device Classification
Risk Class
Class Im
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 15, 2021
Effective Date
April 15, 2021
Manufacturer
Country
France
Address
18 rue Alain Savary, Besancon, 25000