Australia TGA ARTG recordPolymeric spinal fusion cage, non-sterile
Australia TGA ARTG Registered Device · Australian Orthopaedic Fixations Pty Ltd · Australian Orthopaedic Fixations Pty Ltd · Class IIb · Started October 04, 2023
Good Name: Australian Orthopaedic Fixations Pty Ltd - Polymeric spinal fusion cage, non-sterile
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- October 04, 2023
- Effective Date
- October 04, 2023
- Country
- Australia
- Address
- 18 Kinkaid Avenue, NORTH PLYMPTON, SA, 5037
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.
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.