Australia TGA ARTG record

Refobacin® Bone Cement R - Orthopaedic cement, medicated

Australia TGA ARTG Registered Device · Zimmer Biomet Pty Ltd · Biomet France · Class III · Started May 30, 2024

Good Name: Zimmer Biomet Pty Ltd - Refobacin® Bone Cement R - Orthopaedic cement, medicated

Device classification

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

Registration information

Start Date: May 30, 2024
Effective Date: May 30, 2024

Sponsor

Name: Zimmer Biomet Pty Ltd

Manufacturer

Name: Biomet France
Country: France
Address: Plateau de Lautagne, Valence, 26000

Intended purpose

Refobacin® Bone Cement R is indicated to be used for stable anchoring of suitable joint prostheses to the bone, in hip and knee primary arthroplasty operations, also in case an infection with gentamicin-sensitive strains is a potential risk.

About this record

Access comprehensive regulatory information for Refobacin® Bone Cement R - Orthopaedic cement, medicated in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Zimmer Biomet Pty Ltd, manufactured by Biomet France in France. The device registration started on May 30, 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.