Australia TGA ARTG record

Polymeric spinal fusion cage, non-sterile

Australia TGA ARTG Registered Device · E4 Surgical Pty Ltd · Precision Spine Inc · Class IIb · Started October 26, 2021

Good Name: E4 Surgical Pty Ltd - Polymeric spinal fusion cage, non-sterile

Device classification

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

Registration information

Start Date: October 26, 2021
Effective Date: October 26, 2021

Sponsor

Name: E4 Surgical Pty Ltd

Manufacturer

Name: Precision Spine Inc
Country: United States of America
Address: 2050 Executive Drive, Pearl, MI, 39208

Intended purpose

Device indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion.

About this record

Access comprehensive regulatory information for Polymeric spinal fusion cage, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by E4 Surgical Pty Ltd, manufactured by Precision Spine Inc in United States of America. The device registration started on October 26, 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.