Australia TGA ARTG record

Drill bit, surgical

Australia TGA ARTG Registered Device · Optimized Ortho Pty Ltd · Signature Orthopaedics Europe Ltd · Class IIa · Started January 24, 2019

Good Name: Optimized Ortho Ltd - Drill bit, surgical

Device classification

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

Registration information

Start Date: January 24, 2019
Effective Date: January 24, 2019

Sponsor

Name: Optimized Ortho Pty Ltd

Manufacturer

Name: Signature Orthopaedics Europe Ltd
Country: Ireland
Address: Unit A IDA Business & Technology Park Garrycastle, Athlone, Co Westmeath, N37 DY26

Intended purpose

A device that is operated manually or powered that, when rotated will cut into bone creating a hole of the same dimension as the diameter of the bit.

About this record

Access comprehensive regulatory information for Drill bit, surgical in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Optimized Ortho Pty Ltd, manufactured by Signature Orthopaedics Europe Ltd in Ireland. The device registration started on January 24, 2019.

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.