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Fixation device, internal, screw - ARTG 191738

Access comprehensive regulatory information for Fixation device, internal, screw in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 191738 and sponsored by Integrant Pty Ltd, manufactured by Suzhou Youbetter Medical Apparatus Co Ltd in China. The device registration started on November 07, 2011.

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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TGA ARTG Official Data
Class IIb
ARTG 191738
Class IIb
Fixation device, internal, screw
ARTG ID: 191738
Good Name: Integrant Pty Ltd - Fixation device, internal, screw
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DJ Fang

DJ Fang

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Intended Purpose

4.5mm x 60mm cannulated screw used for fixation of fractures and joints following trauma in orthopaedic surgery. The screw is inserted surgically and is also removed surgically approximately 6-8 weeks after insertion. An anatomic example of where this screw would be used is for fractures of the tib-fib joint in the ankle. The screw is used to scross the joint and secure the fracture into position.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
191738
Start Date
November 07, 2011
Effective Date
November 07, 2011
Manufacturer
Country
China
Address
Cheangye Road Jifeng Town, Zhangjiagang City