Australia TGA ARTG record

Lumbar interspinous decompression spacer, sterile

Australia TGA ARTG Registered Device · Orthotech Pty Ltd · Backbone · Class IIb · Started December 10, 2020

Good Name: Orthotech Pty Ltd - Lumbar interspinous decompression spacer, sterile

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 10, 2020
Effective Date: December 10, 2020

Sponsor

Name: Orthotech Pty Ltd

Manufacturer

Name: Backbone
Country: France
Address: 81 Boulevard Pierre 1er, Le Bouscat, 33110

Intended purpose

The LISA implant is intended to stabilize the spinal column by using an operative technique referred to as “non-fusion”. The LISA implant is inserted by posterior approach and dedicated for the lumbar area (from L1 to L5). The LISA implant aims to stabilize the motion segments by preserving natural mobility. The implant is comprised of a spacer designed to be implanted between two lumbar spinous processes and available in various sizes. This spacer is provided with a polyester braid used to hook the spinous processes and a blocker made in titanium alloy to lock the braid into the spacer.

About this record

Access comprehensive regulatory information for Lumbar interspinous decompression spacer, sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Orthotech Pty Ltd, manufactured by Backbone in France. The device registration started on December 10, 2020.

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.