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Lumbar interspinous decompression spacer, sterile

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.

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TGA ARTG Official Data
Class IIb
Class IIb
Lumbar interspinous decompression spacer, sterile
Australia TGA ARTG Registered Device
Good Name: Orthotech Pty Ltd - Lumbar interspinous decompression spacer, sterile
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Intended Purpose

The LISA implant is intended to stabilize the spinal column by using an operative technique referred to as โ€œnon-fusionโ€. 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.

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
Manufacturer
Country
France
Address
81 Boulevard Pierre 1er, Le Bouscat, 33110