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Orthopaedic bone screw, non-biodegradable, non-sterile

Access comprehensive regulatory information for Orthopaedic bone screw, non-biodegradable, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Life Healthcare Pty Ltd, manufactured by Skeletal Dynamics LLC in United States of America. The device registration started on August 31, 2016.

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
Class IIb
Orthopaedic bone screw, non-biodegradable, non-sterile
Australia TGA ARTG Registered Device
Good Name: Life Healthcare Pty Ltd - Orthopaedic bone screw, non-biodegradable, non-sterile
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Intended Purpose

intended for the fixation of osseous fragments or fractures, arthrodesis of small joints and osteotomies with the appropriately sized screw.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 31, 2016
Effective Date
August 31, 2016
Manufacturer
Country
United States of America
Address
7300 N Kendall Dr Suite 400, Miami, Florida, 33156