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Fixation device, internal, spine, construct

Access comprehensive regulatory information for Fixation device, internal, spine, construct in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Medacta Australia Pty Ltd, manufactured by Medacta International SA in Switzerland. The device registration started on June 28, 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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TGA ARTG Official Data
Class IIb
Class IIb
Fixation device, internal, spine, construct
Australia TGA ARTG Registered Device
Good Name: Medacta Australia Pty Ltd - Fixation device, internal, spine, construct
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Intended Purpose

Devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The devices are indicated for posterior non-cervical pedicle fixation (T1-S2/ilium) and nonpedicle fixation, or anterolateral fixation (T8-L5).

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 28, 2024
Effective Date
June 28, 2024
Manufacturer
Country
Switzerland
Address
Strada Regina, Castel San Pietro, CH-6874