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Orthopaedic fixation suture button - ARTG 474793

Access comprehensive regulatory information for Orthopaedic fixation suture button in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 474793 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.

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Class IIb
ARTG 474793
Class IIb
Orthopaedic fixation suture button
ARTG ID: 474793
Good Name: Compliance Management Solutions - Orthopaedic fixation suture button
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Intended Purpose

These fixation suture buttons are intended to be used for fixation of bone-to-bone or soft-tissue-to-bone, as fixation posts, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. They also provide suspension fixation for soft tissue to bone in the repair of natural ligament or tendon disruption or reconstruction of ligament using soft tissue grafts. 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
474793
Start Date
December 24, 2024
Effective Date
December 24, 2024
Manufacturer
Country
India
Address
MD-04 Sanand-II GIDC Ahmedabad, Gujarat, 382 110