ARTG 481327Single-Use Orthopaedic Instruments - Surgical procedure kit, orthopaedic, single-use, non-medicated
ARTG ID: 481327 · Actis Medical Pty Ltd · Paragon 28 Inc · Class IIa · Started February 28, 2025
Good Name: Actis Medical Pty Ltd - Single-Use Orthopaedic Instruments - Surgical procedure kit, orthopaedic, single-use, non-medicated
- Risk Class
- Class IIa
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 481327
- Start Date
- February 28, 2025
- Effective Date
- February 28, 2025
- Name
- Paragon 28 Inc
- Country
- United States of America
- Address
- 14445 Grasslands Drive, Englewood, Colorado, 80112
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.
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.