Australia flagARTG 437312

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

ARTG ID: 437312 · Actis Medical Pty Ltd · Silony Medical GmbH · Class IIa · Started January 24, 2024

Good Name: Actis Medical Pty Ltd - Orthopaedic Fixation System Implantation Kit - Fixation system implantation kit, internal

Device classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration information
ARTG ID
437312
Start Date
January 24, 2024
Effective Date
January 24, 2024
Sponsor
Manufacturer
Country
Germany
Address
Leinfelder Strasse 60, Leinfelden-Echterdingen, 70771
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.

About this record

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 registered under ARTG number 437312 and 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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