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Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile - ARTG 312595

Access comprehensive regulatory information for Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 312595 and sponsored by Zimmer Biomet Pty Ltd, manufactured by Biomet Trauma in United States of America. The device registration started on December 17, 2018.

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 I
ARTG 312595
Class I
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
ARTG ID: 312595
Good Name: Zimmer Biomet Pty Ltd - Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
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Intended Purpose

A sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General-Export
Registration Information
ARTG ID
312595
Start Date
December 17, 2018
Effective Date
December 17, 2018
Manufacturer
Country
United States of America
Address
56 East Bell Drive, Warsaw, IN, 46581