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Orthopaedic bone screw (non-sliding) - ARTG 446431

Access comprehensive regulatory information for Orthopaedic bone screw (non-sliding) in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 446431 and sponsored by Stable Orthopaedics Pty Ltd, manufactured by Chetan Meditech Pvt Ltd in India. The device registration started on April 24, 2024.

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 446431
Class IIb
Orthopaedic bone screw (non-sliding)
ARTG ID: 446431
Good Name: Stable Orthopaedics Pty Ltd - Orthopaedic bone screw (non-sliding)
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Intended Purpose

Orthopaedic bone screws intended to be used as stand-alone bone screws, or in a plate screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the long bones & small bones.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
446431
Start Date
April 24, 2024
Effective Date
April 24, 2024
Manufacturer
Country
India
Address
MD-04 Sanand-II GIDC Ahmedabad, Gujarat, 382 110