Pure Global

Orthopaedic Fixation System Implantation Kit - Fixation system implantation kit, internal

Access comprehensive regulatory information for Orthopaedic Fixation System Implantation Kit - Fixation system implantation kit, internal in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Actis Medical Pty Ltd, manufactured by Silony Medical GmbH in Germany. The device registration started on January 24, 2024.

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 IIa
Class IIa
Orthopaedic Fixation System Implantation Kit - Fixation system implantation kit, internal
Australia TGA ARTG Registered Device
Good Name: Actis Medical Pty Ltd - Orthopaedic Fixation System Implantation Kit - Fixation system implantation kit, internal
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Intended Purpose

A collection of instruments intended to be used for the placement of an internal orthopaedic fixation system into the spine. The kit includes drills, implant trials, and devices intended to connect implants to instruments during surgical procedures. Implantable devices are not included.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
January 24, 2024
Effective Date
January 24, 2024
Manufacturer
Country
Germany
Address
Leinfelder Strasse 60, Leinfelden-Echterdingen, 70771