Australia TGA ARTG record

CP-ESP® disc prosthesis - Cervical total disc replacement prosthesis

Australia TGA ARTG Registered Device · Orthotech Pty Ltd · FH Industrie · Class III · Started January 17, 2024

Good Name: Orthotech Pty Ltd - CP-ESP® disc prosthesis - Cervical total disc replacement prosthesis

Device classification

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

Registration information

Start Date: January 17, 2024
Effective Date: January 17, 2024

Sponsor

Name: Orthotech Pty Ltd

Manufacturer

Name: FH Industrie
Country: France
Address: 6 Rue Nobel, Z.I. de Kernevez, QUIMPER, 29000

Intended purpose

The devices are intended for cervical spine implantation between C3 and C7 during cervical disc arthroplasty.

About this record

Access comprehensive regulatory information for CP-ESP® disc prosthesis - Cervical total disc replacement prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Orthotech Pty Ltd, manufactured by FH Industrie in France. The device registration started on January 17, 2024.

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.