Interspinous spinal fixation implant
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 sponsored by AA-Med Pty Ltd, manufactured by Spinal Simplicity LLC in United States of America. The device registration started on December 15, 2021.
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 Spinal Simplicity Minuteman implants are posterior, non-pedicle supplemental fixation devices, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: • Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); • Spondylolisthesis; • Trauma (i.e., fracture or dislocation); and/or • Tumor. The Minuteman implants are intended for use with bone graft material and is not intended for standalone use. The Minuteman implants may be implanted via a minimally invasive posterior approach (T1-S1) or a minimally invasive lateral approach (L1- S1)*. *Note: The Minuteman G3-R implant may NOT be inserted using a posterior approach.