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Single-Use Orthopaedic Instruments - Surgical procedure kit, orthopaedic, single-use, non-medicated - ARTG 481327

Access comprehensive regulatory information for Single-Use Orthopaedic Instruments - 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 IIa is registered under ARTG number 481327 and sponsored by Actis Medical Pty Ltd, manufactured by Paragon 28 Inc in United States of America. The device registration started on February 28, 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 IIa
ARTG 481327
Class IIa
Single-Use Orthopaedic Instruments - Surgical procedure kit, orthopaedic, single-use, non-medicated
ARTG ID: 481327
Good Name: Actis Medical Pty Ltd - Single-Use Orthopaedic Instruments - Surgical procedure kit, orthopaedic, single-use, non-medicated
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Intended Purpose

A collection of various instruments accompanying the Grappler Suture Anchor System. Devices are intended to assist during orthopaedic surgical procedures, including soft tissue damage repair. Devices are single use.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
481327
Start Date
February 28, 2025
Effective Date
February 28, 2025
Manufacturer
Country
United States of America
Address
14445 Grasslands Drive, Englewood, Colorado, 80112