Pure Global

Optipac Refobacin Plus Bone Cement - Orthopaedic cement, medicated - ARTG 315113

Access comprehensive regulatory information for Optipac Refobacin Plus Bone Cement - 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 315113 and sponsored by Zimmer Biomet Pty Ltd, manufactured by Biomet France in France. The device registration started on March 05, 2019.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class III
ARTG 315113
Class III
Optipac Refobacin Plus Bone Cement - Orthopaedic cement, medicated
ARTG ID: 315113
Good Name: Zimmer Biomet Pty Ltd - Optipac Refobacin Plus Bone Cement - Orthopaedic cement, medicated
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Optipac Refobacin Plus Bone Cement is used for stable anchoring of suitable joint prostheses in primary operations, with added protection against infection also in revision operations resulting from aseptic loosening of the prosthesis and infection of the prosthesis by gentamicin-sensitive strains.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
315113
Start Date
March 05, 2019
Effective Date
March 05, 2019
Manufacturer
Country
France
Address
Plateau de Lautagne, Valence, 26000