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Bone-screw internal spinal fixation system, sterile

Australia TGA ARTG Registered Device · Medtronic Australasia Pty Ltd · Medtronic Sofamor Danek USA Inc · Class IIb · Started September 21, 2023

Good Name: Medtronic Australasia Pty Ltd - Bone-screw internal spinal fixation system, sterile

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
Sponsor
Manufacturer
Country
United States of America
Address
1800 Pyramid Place, Memphis, Tennessee, 38132
Intended purpose

A sterile bone screw spinal implant assembly intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.

About this record

Access comprehensive regulatory information for Bone-screw internal spinal fixation system, 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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