Australia TGA ARTG record

Orthopaedic prosthesis implantation instrument, reusable

Australia TGA ARTG Registered Device · OrthoCentric Pty Ltd · Sayan Tibbi Aletler Pazarlama San ve Tic Ltd Sti · Class IIa · Started March 29, 2023

Good Name: OrthoCentric Pty Ltd - Orthopaedic prosthesis implantation instrument, reusable

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: March 29, 2023
Effective Date: March 29, 2023

Sponsor

Name: OrthoCentric Pty Ltd

Manufacturer

Name: Sayan Tibbi Aletler Pazarlama San ve Tic Ltd Sti
Country: Turkey
Address: Kemalpasa Mahallesi 7110/2 Sokak No 4, Bornova, Izmir, 35060

Intended purpose

SAYAN surgical bone cutting tools are used for bone reshaping, tapping, perforation, grating, and reaming during surgical interventions.

About this record

Access comprehensive regulatory information for Orthopaedic prosthesis implantation instrument, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by OrthoCentric Pty Ltd, manufactured by Sayan Tibbi Aletler Pazarlama San ve Tic Ltd Sti in Turkey. The device registration started on March 29, 2023.

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.