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Surgical procedure kit, orthopaedic, single-use, non-medicated - ARTG 301230

Access comprehensive regulatory information for Surgical procedure kit, orthopaedic, single-use, non-medicated in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 301230 and sponsored by Amplitude Australia Pty Ltd, manufactured by Orthalign Inc in United States of America. The device registration started on March 23, 2018.

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 301230
Class I
Surgical procedure kit, orthopaedic, single-use, non-medicated
ARTG ID: 301230
Good Name: Amplitude Australia Pty Ltd - Surgical procedure kit, orthopaedic, single-use, non-medicated
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Intended Purpose

Resusable instrument kit to be use with OrthAlign PLUS for use in surgical procedures

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
301230
Start Date
March 23, 2018
Effective Date
March 23, 2018
Manufacturer
Country
United States of America
Address
120 Columbia Suite 500, Aliso Viejo, CA, 92656