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Internal spinal fixation procedure kit, reusable - ARTG 482788

Access comprehensive regulatory information for Internal spinal fixation procedure kit, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 482788 and sponsored by AA-Med Pty Ltd, manufactured by Spinal Simplicity LLC in United States of America. The device registration started on March 17, 2025.

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 482788
Class I
Internal spinal fixation procedure kit, reusable
ARTG ID: 482788
Good Name: AA-Med Pty Ltd - Internal spinal fixation procedure kit, reusable
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Intended Purpose

A collection of various orthopaedic manual surgical instruments intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure. This is a reusable device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482788
Start Date
March 17, 2025
Effective Date
March 17, 2025
Sponsor
Manufacturer
Country
United States of America
Address
6363 College Blvd Suite 320, Overland Park, KS, 66211