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Cement spacer mould - ARTG 352206

Access comprehensive regulatory information for Cement spacer mould in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 352206 and sponsored by Life Healthcare Pty Ltd, manufactured by Implantcast GmbH in Germany. The device registration started on December 23, 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 I
ARTG 352206
Class I
Cement spacer mould
ARTG ID: 352206
Good Name: Life Healthcare Pty Ltd - Cement spacer mould
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Intended Purpose

Device used to create a temporary implantable cement spacer at the site of interven-tion. Prepared bone cement is poured into the device, which acts as a mould. After the bone cement has cured, the spacer is removed from the mould and placed into the joint space where it will remain until the infection clears and it is replaced with a conventional joint prosthesis. This is a reusable device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
352206
Start Date
December 23, 2020
Effective Date
December 23, 2020
Manufacturer
Country
Germany
Address
Luneburger Schanze 26, Buxtehude, 21614