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HipAlign Instrument Set - Surgical procedure kit, orthopaedic, single-use, non-medicated - ARTG 298981

Access comprehensive regulatory information for HipAlign Instrument Set - 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 298981 and sponsored by Lima Orthopaedics Australia Pty Ltd, manufactured by Orthalign Inc in United States of America. The device registration started on January 25, 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 298981
Class I
HipAlign Instrument Set - Surgical procedure kit, orthopaedic, single-use, non-medicated
ARTG ID: 298981
Good Name: Lima Orthopaedics Australia Pty Ltd - HipAlign Instrument Set - Surgical procedure kit, orthopaedic, single-use, non-medicated
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Intended Purpose

Reusable marker, guides and instruments for a computer assisted surgery device designed to assist a surgeon in the orientation of the pelvic plane, to determine inclination and anteversion angles of the shell impactor and for the intraoperative measurement of leg length and joint offset during total hip arthroplasty.

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
298981
Start Date
January 25, 2018
Effective Date
January 25, 2018
Manufacturer
Country
United States of America
Address
120 Columbia Suite 500, Aliso Viejo, CA, 92656