Australia TGA ARTG record

Fixation device, internal, spine, construct

Australia TGA ARTG Registered Device · Orthotech Pty Ltd · Humantech Spine GmbH · Class IIb · Started April 05, 2019

Good Name: Orthotech Pty Ltd - Fixation device, internal, spine, construct

Device classification

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

Registration information

Start Date: April 05, 2019
Effective Date: April 05, 2019

Sponsor

Name: Orthotech Pty Ltd

Manufacturer

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

Intended purpose

The Humantech Spinal System, is an internal fixation device for spinal surgery comprised of: rods, pedicle screws, transverse connectors, rod connectors and extension units as well as different types of hooks. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients.

About this record

Access comprehensive regulatory information for Fixation device, internal, spine, construct 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 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.