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Broach, orthopaedic - ARTG 405295

Access comprehensive regulatory information for Broach, orthopaedic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 405295 and sponsored by Stryker Australia Pty Ltd, manufactured by Howmedica Osteonics Corporation in United States of America. The device registration started on February 23, 2023.

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 IIa
ARTG 405295
Class IIa
Broach, orthopaedic
ARTG ID: 405295
Good Name: Stryker Australia Pty Ltd - Broach, orthopaedic
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Intended Purpose

Invasive manual surgical instruments intended for use during hip, knee and osteosynthesis orthopaedic surgeries. Broaches can be used in conjunction with implant trials.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
405295
Start Date
February 23, 2023
Effective Date
February 23, 2023
Manufacturer
Country
United States of America
Address
325 Corporate Drive, Mahwah, New Jersey, 07430