Pure Global

Orthopaedic fixation plate, non-biodegradable

Access comprehensive regulatory information for Orthopaedic fixation plate, non-biodegradable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Stable Orthopaedics Pty Ltd, manufactured by Chetan Meditech Pvt Ltd in India. The device registration started on April 24, 2024.

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 IIb
Class IIb
Orthopaedic fixation plate, non-biodegradable
Australia TGA ARTG Registered Device
Good Name: Stable Orthopaedics Pty Ltd - Orthopaedic fixation plate, non-biodegradable
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Osteotomy and Bone fixation plate used in conjunction with bone screws to provide fixation, intended for use in osteotomies, treatment of bone joint deformities, fixation of fracture, malalignment caused by injury or diseases, such as osteoarthritis of proximal tibia or distal tibia or Distal Femur. A/P (anterior/posterior) sloped osteotomy plates are used where tibial slope adjustments are needed. Osteotomy and Bone fixation plate intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of small bones and bone fragments of the hand/wrist, foot/ankle and osteopenic bone, and for glenohumeral joint by Latarjet/Coracoid Process Transfer in Glenoid rim damage/fracture.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 24, 2024
Effective Date
April 24, 2024
Manufacturer
Country
India
Address
MD-04 Sanand-II GIDC Ahmedabad, Gujarat, 382 110