Pure Global

Fixation system implantation kit, internal

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 sponsored by Evolution Surgical Pty Ltd, manufactured by Life Spine in United States of America. The device registration started on June 18, 2020.

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
Class I
Fixation system implantation kit, internal
Australia TGA ARTG Registered Device
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, taps, drivers, 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
Procedure Pack
ARTG Category
General
Registration Information
Start Date
June 18, 2020
Effective Date
June 18, 2020
Manufacturer
Country
United States of America
Address
13951 S Quality Dr, Huntley, Illinois, 60142