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Metal-polymer composite spinal fusion cage - ARTG 316185

Access comprehensive regulatory information for Metal-polymer composite spinal fusion cage in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 316185 and sponsored by Orthotech Pty Ltd, manufactured by Humantech Spine GmbH in Germany. The device registration started on April 05, 2019.

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 IIb
ARTG 316185
Class IIb
Metal-polymer composite spinal fusion cage
ARTG ID: 316185
Good Name: Orthotech Pty Ltd - Metal-polymer composite spinal fusion cage
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Intended Purpose

The Humantech Peek+Ti Interbody Fusion cage is intended for the fusion of vertebral bodies in spinal surgery for the operative treatment of diseases and injuries of the spine, the device is comprised of intervertebral implants in different sizes, angles and heights, enabling adaptations to be made while taking into account the unique pathology of the individual patient.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
316185
Start Date
April 05, 2019
Effective Date
April 05, 2019
Manufacturer
Country
Germany
Address
Gewerbestrasse 5, Steinenbronn, 71144