Australia TGA ARTG recordPolymeric spinal fusion cage, non-sterile
Australia TGA ARTG Registered Device · Kynesis Pty Ltd · Australian Orthopaedic Fixations Pty Ltd · Class IIb · Started October 12, 2023
Good Name: Kynesis Pty Ltd - Polymeric spinal fusion cage, non-sterile
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- October 12, 2023
- Effective Date
- October 12, 2023
- Name
- Kynesis Pty Ltd
- Country
- Australia
- Address
- 18 Kinkaid Avenue, NORTH PLYMPTON, SA, 5037
Device generally indicated for lumbar and lumbosacral pathologies indicated for segmental arthrodesis, 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.
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 Australian Orthopaedic Fixations Pty Ltd in Australia. The device registration started on October 12, 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.