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Optipac® Refobacin® Bone Cement R - Orthopaedic cement, medicated - ARTG 450207

Access comprehensive regulatory information for Optipac® 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 registered under ARTG number 450207 and 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.

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Class III
ARTG 450207
Class III
Optipac® Refobacin® Bone Cement R - Orthopaedic cement, medicated
ARTG ID: 450207
Good Name: Zimmer Biomet Pty Ltd - Optipac® Refobacin® Bone Cement R - Orthopaedic cement, medicated
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Intended Purpose

Optipac® 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.

Device Classification
Risk Class
Class III
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
450207
Start Date
May 30, 2024
Effective Date
May 30, 2024
Manufacturer
Country
France
Address
Plateau de Lautagne, Valence, 26000