Pure Global

Polymeric spinal fusion cage, non-sterile

Access comprehensive regulatory information for Polymeric spinal fusion cage, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Australian Orthopaedic Fixations Pty Ltd, manufactured by Australian Orthopaedic Fixations Pty Ltd in Australia. The device registration started on October 04, 2023.

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
Class IIb
Polymeric spinal fusion cage, non-sterile
Australia TGA ARTG Registered Device
Good Name: Australian Orthopaedic Fixations Pty Ltd - Polymeric spinal fusion cage, non-sterile
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

A polymer disc spacer used for the support of the intervertebral space to allow bone fusion following posterior lumbar surgical procedures. The spacer is intended to be used for the treatment of a variety of indications in the lumbar spine including Degenerative Disc Disease (DDD), Degenerative Lumbar Scoliosis spondylolisthesis, retrolisthesis, revision surgery, stenosis and pseudarthrosis.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 04, 2023
Effective Date
October 04, 2023
Manufacturer
Country
Australia
Address
18 Kinkaid Avenue, NORTH PLYMPTON, SA, 5037