Pure Global

Orthopaedic bone washer, non-sterile - ARTG 469347

Access comprehensive regulatory information for Orthopaedic bone washer, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 469347 and sponsored by Actis Medical Pty Ltd, manufactured by Paragon 28 Inc in United States of America. The device registration started on November 19, 2024.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
ARTG 469347
Class IIb
Orthopaedic bone washer, non-sterile
ARTG ID: 469347
Good Name: Actis Medical Pty Ltd - Orthopaedic bone washer, non-sterile
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The Gorilla® Plating System implants are internal fixation systems. Plates are offered in “mini” and “standard” set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in “mini” and “standard” sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non-locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw. Implants are manufactured from commercially pure titanium or titanium alloy.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
469347
Start Date
November 19, 2024
Effective Date
November 19, 2024
Manufacturer
Country
United States of America
Address
14445 Grasslands Drive, Englewood, Colorado, 80112