Australia TGA ARTG record

Polymeric spinal fusion cage, non-sterile

Australia TGA ARTG Registered Device · Kynesis Pty Ltd · CANWELL MEDICAL CO LTD · Class IIb · Started November 26, 2020

Good Name: Kynesis Pty Ltd - Polymeric spinal fusion cage, non-sterile

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: November 26, 2020
Effective Date: November 26, 2020

Sponsor

Name: Kynesis Pty Ltd

Manufacturer

Name: CANWELL MEDICAL CO LTD
Country: China
Address: No 466 South Xianhua Street High-Tech Industrial Zone Jinhua, Zhejiang, 321016

Intended purpose

The cage is indicated for lumbar and lumbosacral pathologies indicated for segmental arthrodesis in skeletally mature patients, including: degenerative discopathy; primary surgery for advanced discopathies or extensive destabilisation decompressions; revision surgery for failed disc and surgery (i.e. recurrent disc herniation, post-operative instability); lumbar pseudarthrosis, certain lumbar stenosis; degenerative and isthmic spondylolisthesis with grade I residual displacement after reduction.

About this record

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 Kynesis Pty Ltd, manufactured by CANWELL MEDICAL CO LTD in China. The device registration started on November 26, 2020.

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.