Pure Global

Polymeric spinal fusion cage, non-sterile

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.

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TGA ARTG Official Data
Class IIb
Class IIb
Polymeric spinal fusion cage, non-sterile
Australia TGA ARTG Registered Device
Good Name: E4 Surgical Pty Ltd - Polymeric spinal fusion cage, non-sterile
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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.

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
Manufacturer
Country
United States of America
Address
2050 Executive Drive, Pearl, MI, 39208