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Prosthesis, internal, spine, vertebral body - ARTG 372782

Access comprehensive regulatory information for Prosthesis, internal, spine, vertebral body in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 372782 and sponsored by Orthotech Pty Ltd, manufactured by Humantech Spine GmbH in Germany. The device registration started on August 13, 2021.

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 372782
Class IIb
Prosthesis, internal, spine, vertebral body
ARTG ID: 372782
Good Name: Orthotech Pty Ltd - Prosthesis, internal, spine, vertebral body
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Intended Purpose

Cervical Vertebral Body Replacement System (VBR) is an implant system for long-term use for anterior stabilization of the cervical spine as a replacement for one or more vertebral bodies in patients in whom general skeletal growth has ceased. Application is intended for an anterior approach.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
372782
Start Date
August 13, 2021
Effective Date
August 13, 2021
Manufacturer
Country
Germany
Address
Gewerbestrasse 5, Steinenbronn, 71144