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Fixation system implantation kit, internal - ARTG 355782

Access comprehensive regulatory information for Fixation system implantation kit, internal in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 355782 and sponsored by Evolution Surgical Pty Ltd, manufactured by Ulrich Medical USA Inc in United States of America. The device registration started on February 26, 2021.

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 I
ARTG 355782
Class I
Fixation system implantation kit, internal
ARTG ID: 355782
Good Name: Evolution Surgical Pty Ltd - Fixation system implantation kit, internal
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Intended Purpose

A collection of reusable instruments intended to be used for the placement of an internal orthopaedic fixation system. Includes various metallic and/or plastic reusable devices (e.g. awls, bending and compression / distraction instruments, inserters, handles, wound retractors, clamps, pins, cutters, screwdrivers, guides, impactors, etc.) that are specific to the fixation system applied.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
355782
Start Date
February 26, 2021
Effective Date
February 26, 2021
Manufacturer
Country
United States of America
Address
3700 E Plano Pkwy Suite 200, Plano, TX, 75074