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Drill bit, surgical

Australia TGA ARTG Registered Device · OrthoCentric Pty Ltd · OrthoCentric Pty Ltd · Class IIa · Started May 31, 2024

Good Name: OrthoCentric Pty Ltd - Drill bit, surgical

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
May 31, 2024
Effective Date
May 31, 2024
Sponsor
Manufacturer
Country
Australia
Address
21/76 Reserve Road, ARTARMON, NSW, 2064
Intended purpose

A device that is mounted into a surgical drilling machine, and that, when rotated at an appropriate speed, will cut into bone creating a hole of the same dimension as the diameter of the bit. It will typically have the form of a "twist drill" (spiralled), but some may be flat with a bevelled cutting edge. The device is provided sterile for single use for orthopaedic surgery to assist in insertion of implants.

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 OrthoCentric Pty Ltd, manufactured by OrthoCentric Pty Ltd in Australia. The device registration started on May 31, 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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