Pure Global

Spinal cage

Access comprehensive regulatory information for Spinal cage in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Evolution Surgical Pty Ltd, manufactured by Kyocera Medical Technologies in United States of America. The device registration started on February 02, 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.

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TGA ARTG Official Data
Class IIb
Class IIb
Spinal cage
Australia TGA ARTG Registered Device
Good Name: Evolution Surgical Pty Ltd - Spinal cage
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Intended Purpose

The KMTI interbody cages are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the spine. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 02, 2021
Effective Date
February 02, 2021
Manufacturer
Country
United States of America
Address
1200 California Street Suite 210, Redlands, California, 92374