Australia TGA ARTG record

Polymeric spinal fusion cage, sterile

Australia TGA ARTG Registered Device · Orthotech Pty Ltd · Humantech Spine GmbH · Class IIb · Started November 19, 2020

Good Name: Orthotech Pty Ltd - Polymeric spinal fusion cage, sterile

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: November 19, 2020
Effective Date: November 19, 2020

Sponsor

Name: Orthotech Pty Ltd

Manufacturer

Name: Humantech Spine GmbH
Country: Germany
Address: Gewerbestrasse 5, Steinenbronn, 71144

Intended purpose

Device is used as an implant system for the fusion of vertebrae bodies in spine column surgery (cages). The PEEK cages are available in different dimensions, enabling adaptations to be made while taking into account the unique pathology of the individual patient.

About this record

Access comprehensive regulatory information for Polymeric spinal fusion cage, sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Orthotech Pty Ltd, manufactured by Humantech Spine GmbH in Germany. The device registration started on November 19, 2020.

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.