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Bone-screw internal spinal fixation system, sterile - ARTG 422154

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 registered under ARTG number 422154 and 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
ARTG 422154
Class IIb
Bone-screw internal spinal fixation system, sterile
ARTG ID: 422154
Good Name: Medtronic Australasia Pty Ltd - Bone-screw internal spinal fixation system, sterile
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Intended Purpose

The bone screw components of an internal spinal fixation system, intended to be used with a fusion device, to promote bone fusion during the normal healing process following surgical correction of disorders of the spine.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
422154
Start Date
September 21, 2023
Effective Date
September 21, 2023
Manufacturer
Country
United States of America
Address
1800 Pyramid Place, Memphis, Tennessee, 38132