Interspinous spinal fixation implant - ARTG 467788
Access comprehensive regulatory information for Interspinous spinal fixation implant in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 467788 and sponsored by AA-Med Pty Ltd, manufactured by Spinal Simplicity LLC in United States of America. The device registration started on November 08, 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.
The subject devices are posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1 ). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions: • Lumbar spinal stenosis; • degenerative disc disease (DOD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or • spondylolisthesis. The subject devices are intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1)