ARTG 467788Interspinous spinal fixation implant
ARTG ID: 467788 · AA-Med Pty Ltd · Spinal Simplicity LLC · Class IIb · Started November 08, 2024
Good Name: AA-Med Pty Ltd - Interspinous spinal fixation implant
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 467788
- Start Date
- November 08, 2024
- Effective Date
- November 08, 2024
- Name
- AA-Med Pty Ltd
- Country
- United States of America
- Address
- 6363 College Blvd Suite 320, Overland Park, KS, 66211
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)
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.
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