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Surgical instrument torque-limiting handle - ARTG 484449

Access comprehensive regulatory information for Surgical instrument torque-limiting handle in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 484449 and sponsored by Stryker Australia Pty Ltd, manufactured by Stryker GmbH in Switzerland. The device registration started on March 27, 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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Class I
ARTG 484449
Class I
Surgical instrument torque-limiting handle
ARTG ID: 484449
Good Name: Stryker Australia Pty Ltd - Surgical instrument torque-limiting handle
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Intended Purpose

A hand-held manual surgical instrument designed to attach to a surgical instrument. During an orthopaedic procedure, allows manipulation with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened. This is a reusable device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
484449
Start Date
March 27, 2025
Effective Date
March 27, 2025
Manufacturer
Country
Switzerland
Address
Bohnackerweg 1, Selzach, 2545