Pure Global

Spinal fixation plate, non-biodegradable - ARTG 462407

Access comprehensive regulatory information for Spinal fixation plate, non-biodegradable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 462407 and sponsored by Evolution Surgical Pty Ltd, manufactured by Kyocera Medical Technologies in United States of America. The device registration started on September 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 462407
Class IIb
Spinal fixation plate, non-biodegradable
ARTG ID: 462407
Good Name: Evolution Surgical Pty Ltd - Spinal fixation plate, non-biodegradable
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The Anterior Cervical Plate System is intended for anterior plate and screw fixation of the cervical spine as an adjunct to fusion. The plates and screws have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease, spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumour, pseudarthrosis or failed previous fusion.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
462407
Start Date
September 19, 2024
Effective Date
September 19, 2024
Manufacturer
Country
United States of America
Address
1200 California Street Suite 210, Redlands, California, 92374