Pure Global

Orthopaedic bone screw (non-sliding) - ARTG 474795

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 474795 and sponsored by Compliance Management Solutions, manufactured by Chetan Meditech Pvt Ltd in India. The device registration started on December 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
ARTG 474795
Class IIb
Orthopaedic bone screw (non-sliding)
ARTG ID: 474795
Good Name: Compliance Management Solutions - Orthopaedic bone screw (non-sliding)
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

These devices are intended to be used for fixation of tissue to bone, including ligament or tendon to bone, or a bone to bone. They can also use 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. These devices are also intended to provide soft tissue reattachment (i.e. fixation of ligament and tendon graft tissue). These devices may be used in either arthroscopic or open surgical procedures

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
474795
Start Date
December 24, 2024
Effective Date
December 24, 2024
Manufacturer
Country
India
Address
MD-04 Sanand-II GIDC Ahmedabad, Gujarat, 382 110