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Polymeric spinal fusion cage, sterile

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.

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Class IIb
Class IIb
Polymeric spinal fusion cage, sterile
Australia TGA ARTG Registered Device
Good Name: Orthotech Pty Ltd - Polymeric spinal fusion cage, sterile
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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.

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
Manufacturer
Country
Germany
Address
Gewerbestrasse 5, Steinenbronn, 71144