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Orthopaedic bone screw, non-bioabsorbable, sterile - ARTG 396253

Access comprehensive regulatory information for Orthopaedic bone screw, non-bioabsorbable, sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 396253 and sponsored by Medical & Optical Instruments Australia Pty Ltd, manufactured by ExsoMed Corporation in United States of America. The device registration started on September 21, 2022.

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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TGA ARTG Official Data
Class IIb
ARTG 396253
Class IIb
Orthopaedic bone screw, non-bioabsorbable, sterile
ARTG ID: 396253
Good Name: Medical & Optical Instruments Australia Pty Ltd - Orthopaedic bone screw, non-bioabsorbable, sterile
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Intended Purpose

Orthopaedic bone screw, non-bioabsorbable, sterile for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
396253
Start Date
September 21, 2022
Effective Date
September 21, 2022
Manufacturer
Country
United States of America
Address
135 Columbia Suite 201, Aliso Viejo, California, 92656