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Bone-screw internal spinal fixation system, non-sterile

Access comprehensive regulatory information for Bone-screw internal spinal fixation system, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Medtronic Australasia Pty Ltd, manufactured by Medtronic Sofamor Danek USA Inc in United States of America. The device registration started on September 21, 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.

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TGA ARTG Official Data
Class IIb
Class IIb
Bone-screw internal spinal fixation system, non-sterile
Australia TGA ARTG Registered Device
Good Name: Medtronic Australasia Pty Ltd - Bone-screw internal spinal fixation system, non-sterile
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Intended Purpose

A non-sterile bone screw spinal fixation system intended to help provide immobilisation and stabilisation of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 21, 2023
Effective Date
September 21, 2023
Manufacturer
Country
United States of America
Address
1800 Pyramid Place, Memphis, Tennessee, 38132