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Fixation device, internal, spine, construct - ARTG 316187

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 registered under ARTG number 316187 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 316187
Class IIb
Fixation device, internal, spine, construct
ARTG ID: 316187
Good Name: Orthotech Pty Ltd - Fixation device, internal, spine, construct
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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.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
316187
Start Date
April 05, 2019
Effective Date
April 05, 2019
Manufacturer
Country
Germany
Address
Gewerbestrasse 5, Steinenbronn, 71144