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Orthopaedic bone screw, non-bioabsorbable, sterile

Australia TGA ARTG Registered Device · Australian Orthopaedic Fixations Pty Ltd · Australian Orthopaedic Fixations Pty Ltd · Class IIb · Started December 02, 2021

Good Name: Australian Orthopaedic Fixations Pty Ltd - Orthopaedic bone screw, non-bioabsorbable, sterile

Device classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
December 02, 2021
Effective Date
December 02, 2021
Sponsor
Manufacturer
Country
Australia
Address
18 Kinkaid Avenue, NORTH PLYMPTON, SA, 5037
Intended purpose

A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

About this record

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 sponsored by Australian Orthopaedic Fixations Pty Ltd, manufactured by Australian Orthopaedic Fixations Pty Ltd in Australia. The device registration started on December 02, 2021.

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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